PowerFlow Implantable Apheresis IV Port Instructions For Use

Description

The PowerFlow Implantable Apheresis IV Port is a totally implantable vascular access device designed to provide repeated access to the vascular system and flow rates as high as 150 mL/min. It is designed for easy placement, easy access, and continuous flow for apheresis procedures.

The PowerFlow IV Port consists of two primary components: a titanium access funnel with soft silicone body and a 9.6F radiopaque CHRONOFLEX™ polyurethane catheter. The two components are connected with a radiopaque catheter lock. A unique silicone valve and seal assembly inside the access funnel keeps the port system closed. The PowerFlow IV Port can be identified subcutaneously by finding the high point of the device and palpating the funnel as it slopes down and away from this point. This area is the entrance to the device and will feel concave and hollow.

PowerFlow™ Parts Diagram

PowerFlow IV Port access is performed at a shallow angle by the percutaneous insertion of an over-the- needle intravenous (IV) catheter (BD INSYTE™ AUTOGUARD™ Shielded IV Catheter, 16 or 14 gauge, 1.75” minimum length). The access funnel helps guide the IV needle into the angled pathway and to the needle stop. The needle cannot pass beyond the needle stop by design; however, once the needle is separated from the flexible IV catheter and pulled away slightly, the IV catheter can be advanced through the access pathway to open the valve and gain access.

PowerFlow™ Access Angle Diagram

The PowerFlow IV Port is not accessed with Huber non-coring needles. All materials are biocompatible and can be used with a broad range of injectable solutions intended for medicinal use, including the power injection of contrast media. The unique radiopaque identifier on the bottom of the port helps identify it as power injectable and accessed with an IV.

PowerFlow™ Radiopaque Identifier

Indications for Use

The Bard PowerFlow Implantable Apheresis IV Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, IV fluids, parenteral nutrition solutions, blood and blood products.

The Bard PowerFlow Implantable Apheresis IV Port is indicated for power injection of contrast media.

For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.

Contraindications

This device is contraindicated for:

  • Catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates of pinch-off.1,2 Port catheter may be placed in lateral subclavian vein based on evaluation by a qualified practitioner.
  • When the presence of infection, bacteremia, or septicemia is known or suspected at the prospective port placement site.
  • When the patient’s vasculature and/or body size is insufficient for the size of the implanted device.
  • Placement in the patient arm, due to device size and potential heating effect in an MR system.
  • When the patient is known or is suspected to be allergic to materials contained in the device or placement components.
    • The implanted device is primarily composed of titanium, silicone, polycarbonate and/or polyurethane.
    • Contact the Bard Clinical Information Hotline at 800-555-7422 for additional information on placement components.
  • If severe chronic obstructive pulmonary disease exists.
  • If the prospective insertion site has been previously irradiated.
  • If the prospective placement site has previously suffered episodes of venous thrombosis or vascular surgical procedures.
  • If local tissue factors will prevent proper device stabilization and/or access.
  • Hemodialysis, as the safety and effectiveness has not been established for this therapy.

Warnings

  1. During Placement:
    • Intended for Single Use. Do not reuse. Reuse and/or repackaging may create risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure and/or lead to injury, illness or death of the patient.
    • Alcohol should not be used to soak, declot or lock the device or polyurethane catheters because alcohol is known to degrade the product materials over time with repeated and prolonged exposure.
    • Cardiac arrhythmias may result if the guidewire touches the walls of the right atrium. Use cardiac rhythm monitoring to detect arrhythmias.
    • After use, this product may be a potential biohazard. Handle and discard in accordance with accepted medical practice and applicable local, state and federal laws and regulations.
    • Place a gloved finger over exposed opening of sheath or needle or attach syringe filled with sterile normal saline solution to minimize blood loss and prevent air embolism. The risk of air embolism is reduced by performing this part of the procedure with the patient performing the Valsalva maneuver and/or in Trendelenburg position.
    • Do not suture catheter to port, port stem, or surrounding tissue. Any damage or constriction of catheter may compromise power injection performance and catheter integrity. Bard does not recommend suturing around the catheter as doing so could compress, kink, or damage catheter, including catheter fragmenting and/or fracturing.
    • Needle access should be accomplished using Seldinger technique. Passage of the guidewire, sheath, introducer and catheter should also be performed with Seldinger technique with careful attention to the signs and symptoms of vessel perforation. Should there be concern for vessel perforation, appropriate diagnostic testing should be performed.
    • Do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure.
  2. During Port Access:
    • Failure to confirm IV catheter placement may result in infiltration/extravasation.
    • If high dose heparin (1,000 – 5,000 units/mL) is used, aspirate the solution out of the device before use to prevent systemic heparinization of the patient.
    • DO NOT USE A SYRINGE SMALLER THAN 10 mL TO FLUSH AND CONFIRM PATENCY. Patency should be assessed with a 10 mL syringe or larger with sterile normal saline. Upon confirmation of patency, administration of medication should be given in a syringe appropriately sized for the dose. Do not infuse against resistance.
    • PowerFlow IV Ports are only power injectable when accessed with the BD INSYTE™ AUTOGUARD™ Shielded IV Catheter.
    • Failure to warm contrast media to body temperature prior to power injection may result in port system failure.
    • Failure to ensure patency of the catheter prior to power injection studies may result in port system failure.
    • Power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.
    • Exceeding the maximum power injection flow rate may result in port system failure.
    • PowerFlow IV Port system indication for power injection of contrast media implies the port’s ability to withstand the procedure, but it does not imply appropriateness of the procedure for a particular patient nor for a particular IV catheter. A suitably trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure and for evaluating the suitability of any IV catheter used to access the port.
    • Do not exceed a 300 psi pressure limit setting on the power injection machine, or the maximum recommended flow rate on the IV catheter, if power injecting through the PowerFlow IV Port (max infusion rate is 5mL/s).
    • If local pain, swelling or signs of extravasation are noted during power injection, the injection should be stopped immediately.

Precautions

  • Carefully read and follow all instructions in these instructions for use.
  • Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
  • Only qualified healthcare practitioners should insert, manipulate and remove these devices.
  • Avoid inadvertent puncture of the skin or fascia with the tip of the tunneler.
  • If the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.
  • Prior to advancing the catheter lock, ensure that the catheter is properly positioned. A catheter not advanced to the proper region of the stem may not seat securely and lead to dislodgement and extravasation. The catheter must be straight with no sign of kinking. A slight pull on the catheter is sufficient to straighten it. Advancing the catheter lock over a kinked catheter may damage the catheter.
  • Do not hold the catheter or cathlock with any instruments that could potentially damage either piece (e.g. hemostats).
  • Follow universal precautions when inserting and maintaining the catheter.
  • Follow all contraindications, warnings, precautions and instructions for all infusates as specified by their manufacturers.

I. Prior to Placement

  • Examine package carefully before opening to confirm its integrity and that the expiration date has not passed. The device is supplied in a double sterile package and is non-pyrogenic. Do not use if package is damaged, opened or the expiration date has passed. Sterilized using ethylene oxide. Do not re-sterilize.
  • Inspect kit for presence of all components.
  • Check patient’s records, and ask patient, whether they have any known allergies to chemicals or materials that will be used during the placement procedure.
  • Fill (prime) the device with sterile normal saline solution to help avoid air embolism.
  • When using an introducer kit, verify that the catheter fits easily through the introducer sheath.
  • Bard recommends the use of components provided in the kit. If additional items are to be used, check for proper fit prior to utilization.
  • NOTE: Port body, catheter and catheter lock cannot be replaced with components outside the provided kit.

II. During Placement

  • Do not allow accidental device contact with sharp instruments. Mechanical damage may occur. Use only smooth edged, atraumatic clamps or forceps.
  • Take care not to perforate, tear, or fracture the catheter during placement. After assembling catheter to port, check assembly for leaks or damage.
  • Do not use the catheter if there is any evidence of mechanical damage or leaking.
  • Do not bend catheter at sharp angles during implantation. This can compromise catheter patency.
  • Carefully follow the connection technique given in these instructions to ensure proper catheter connection and to avoid catheter damage.
  • Do not use sutures to secure catheter to the port stem as it could collapse or damage the catheter.
  • When using peel-apart introducers:
    • Carefully insert the introducer and catheter to avoid inadvertent penetration to vital structures in the thorax.
    • Avoid blood vessel damage by maintaining a catheter or dilator as internal support when using a peel-apart introducer.
    • Avoid sheath damage by simultaneously advancing the sheath and dilator as a single unit using a rotational motion.
  • Never use a catheter lock that appears cracked or otherwise damaged.
  • Remember that some patients may be hyper-sensitive to heparin or suffer from heparin induced thrombocytopenia (HIT). These patients must not have their port locked with heparinized saline.

III. After Placement:

  • Encourage patient to keep patient ID card and present it to clinicians accessing their port.
  • Care should be taken to avoid excessive force when accessing an implanted port.
  • PowerFlow IV Port is not accessed with Huber non-coring needles. To access the PowerFlow IV Port, use BD INSYTE™ AUTOGUARD™ Shielded IV Catheters, 16G or 14G, 1.75 inches (44mm) or longer. The exact IV catheter length should be determined by the clinical situation.
  • Use only non-hydrophilic IV catheters.
  • Do not bend the needle while using the product.
  • Do not reuse or reinsert the needle into the IV catheter. Reinsertion of the needle may cause damage to the IV catheter, which may lead to extravasation.
  • For safety needles, if needle retraction does not occur, depress button again. Dispose of any unshielded needles immediately. Keep needlepoint away from body and fingers at all times.
  • The IV catheter hub should not be left open to air while it is in the port.
  • During MRI, RF heating behavior for the Bard PowerFlow Apheresis IV Port does not scale with static field strengths and has not been evaluated for static field strengths above 3 T.

Possible Complications

The use of a subcutaneous port provides an important means of venous access for critically ill patients.

However, the potential exists for serious complications, including the following:

  • Air Embolism
  • Allergic Reaction
  • Bleeding
  • Brachial Plexus Injury
  • Cardiac Arrhythmia
  • Cardiac Puncture
  • Cardiac Tamponade
  • Catheter or Port Erosion Through the Skin
  • Catheter Embolism
  • Catheter Occlusion
  • Catheter or Port-Related Sepsis
  • Damage or Breakage due to Compression Between the Clavicle and First Rib
  • Device Rotation or Extrusion
  • Endocarditis
  • Extravasation
  • Fibrin Sheath Formation
  • Guidewire Fragment Embolism
  • Hematoma
  • Hemothorax
  • Hydrothorax
  • Infection, including but not limited to pocket, catheter tunnel, and/or blood stream
  • Inflammation, Necrosis, or Scarring of Skin Over Implant Area
  • Intolerance or Reaction to Implanted Device
  • Laceration of Vessels or Viscus
  • Pain at or around pocket site
  • Perforation of Vessels or Viscus
  • Pneumothorax
  • Risks Normally Associated With Local or General Anesthesia, Surgery, and Post-Operative Recovery
  • Spontaneous Catheter Tip Malposition or Retraction
  • Thoracic Duct Injury
  • Thromboembolism
  • Vascular Thrombosis
  • Vessel Erosion

These and other complications are well documented in medical literature and should be carefully considered before placing the port.

Implantation Instructions

Please read through complete implantation instructions before implanting port, noting “Contraindications, Warnings, and Precautions” and “Possible Complications” sections of this manual before beginning procedure. Clinical judgment should be exercised when considering appropriate patient population; see contraindications for patient considerations.

If two systems are being considered for placement, please refer to the packaging insert for recirculation rates for various catheter tip locations.

Preventing Pinch-Off

Clinical:

Difficulty with blood withdrawal

  • Resistance to infusion of fluids
  • Patient position changes required for infusion of fluids or blood withdrawal

Radiologic:

  • Grade 1 or 2 distortion on chest X-ray. Pinch-off should be evaluated for degree of severity prior to explanation. Patients indicating any degree of catheter distortion at the clavicle/first rib area should be followed diligently. There are grades of pinch-off that should be recognized with appropriate chest x-ray as shown in the table.3,4
Grade and Severity Table

Implantation Preparation

1. Select the pocket site for port placement.

NOTE: Port pocket site selection should allow for port placement in an anatomic area that:

  • provides good device stability
  • does not interfere with patient mobility or daily activities
  • does not create pressure points
  • has not previously been irradiated
  • does not show signs of infection
  • does not interfere with clothing
  • does not interfere with other implanted medical devices

Ideally choose an implantation site in the lateral infraclavicular region for cosmesis and functionality.

Consider the amount of cutaneous tissue over the port funnel, as excessive tissue will make access difficult. Conversely, too thin a tissue layer over the port may lead to tissue erosion. A tissue thickness of 0.5 cm to 1.5 cm is appropriate.

2. Initiate patient implant record, including product code and lot number.

3. Perform adequate anesthesia.

4. Create sterile field and open tray.

NOTE: The catheter and port may be soaked in sterile normal saline prior to placement.

5. Surgically prep and drape the implantation site.

6. Flush the catheter with sterile normal saline, through the flushing connector.

7. Place patient in the Trendelenburg position with head turned away from the intended venipuncture site.

NOTE: Recommended veins for chest placement are internal jugular or lateral subclavian. Refer to the note above covering catheter pinch-off if inserting the catheter via the subclavian vein.

Percutaneous Procedure

1. Locate and access vessel with introducer needle attached to a syringe.

NOTE: Vessel location may be facilitated using imaging guidance.

Percutaneous Procedure Step One

2. Aspirate gently as the insertion is made. If the artery is entered, withdraw the needle and apply manual pressure for several minutes. If the pleural space is entered, withdraw the needle and evaluate patient for possible pneumothorax.

Percutaneous Procedure Step Two

3. When the vein has been entered, remove the syringe leaving the needle in place.

WARNING: Place a gloved finger over exposed opening of needle to minimize blood loss and prevent air embolism. The risk of air embolism is reduced by performing this part of the procedure with the patient performing the Valsalva maneuver and/or in Trendelenburg position.

Percutaneous Procedure Step Three

4. If using a micropuncture set,

  1. a) Insert the flexible end of the micropuncture guidewire into the introducer needle.
  2. b) Advance the guidewire as far as appropriate.
  3. c) Verify correct positioning, using fluoroscopy or appropriate technology.
  4. d) Gently withdraw and remove the needle, while holding the micropuncture guidewire in position.
  5. e) Advance the small sheath and dilator together as a unit over the micropuncture guidewire, using a slight rotational motion.
  6. f) Withdraw the dilator and guidewire, leaving the microintroducer sheath in place.

CAUTION: If the guidewire must be withdrawn while the needle is inserted, remove both needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.

WARNING: Place thumb over opening of sheath to minimize blood loss and prevent air embolism. The risk of air embolism is reduced by performing this part of the procedure with the patient performing the Valsalva maneuver and/or in Trendelenburg position.

5. Straighten “J” tip of standard guidewire with tip straightener and insert tapered end of tip straightener into the needle (or microintroducer sheath if using a micropuncture set).

NOTE: Do not advance guidewire if obstruction is encountered.

Percutaneous Procedure Step Five

6. Remove the tip straightener and advance the guidewire into the superior vena cava. Advance the guidewire as far as appropriate for the procedure. Verify correct positioning using fluoroscopy or appropriate technology.

Percutaneous Procedure Step Six

7. Gently withdraw and remove needle (or microintroducer sheath if using micropuncture set).

CAUTION: If the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to help prevent the needle from damaging or shearing the guidewire.

Peel-Apart Sheath Introducer Instructions

1. Advance the vessel dilator and sheath introducer as a unit over the exposed wire using a rotational motion. Advance it into the vein as a unit, leaving at least 2 cm of sheath exposed.

NOTE: Placement may be facilitated by making a small incision next to the guidewire to ease introduction of vessel dilator and sheath introducer.

WARNING: Avoid vessel perforation.

Peel-Apart Sheath Introducer Instructions Step 1 Diagram

2. Release the locking mechanism and gently withdraw the vessel dilator and “J” wire, leaving the sheath in place.

WARNING: Place gloved finger over exposed opening of sheath to minimize blood loss and prevent air embolism, if needed. The risk of air embolism is reduced by performing this part of the procedure with the patient performing the Valsalva maneuver and/or in Trendelenburg position.

Peel-Apart Sheath Introducer Instructions Step 2 Diagram

3. Remove catheter lock from the catheter.

CAUTION: Never use a catheter lock that appears cracked or otherwise damaged.

4. Insert catheter tip into the sheath. Advance the catheter through the sheath into the vessel to the desired location. Catheters should be positioned with the catheter tip at the junction of the superior vena cava and the right atrium.

NOTE: If placing two port catheters, please refer to the packaging insert for Recirculation Information.

Peel-Apart Sheath Introducer Instructions Step 3 and 4 Diagram

5. Verify correct catheter tip position using fluoroscopy or appropriate technology.

6. Grasp the two handles of the peel-apart sheath and pull outward and upward at the same time. Peel the sheath away from the catheter completely. Make sure the catheter remains in place.

Peel-Apart Sheath Introducer Instructions Step 5 and 6 Diagram

Pocket Creation/Catheter Tunneling Procedure

1. Return to the selected port pocket site and numb the area with lidocaine. Create a subcutaneous pocket using blunt dissection.

NOTE: Do a trial placement to verify that the pocket is large enough to accommodate the port and that the port does not lie beneath the incision. Consider the amount of cutaneous tissue over the port funnel, as excessive tissue will make access difficult. Conversely, too thin a tissue layer over the port may lead to tissue erosion. A tissue thickness of 0.5 cm to 1.5 cm is appropriate.

2. Create a subcutaneous tunnel from the venous site to the port pocket site using tunneler or long forceps per the following:

  1. a) Make a small incision at the venous entry site.
  2. b) Insert tip of tunneler into the small incision.
  3. c) Form tunnel by advancing tip of tunneler from the venous entry site to the port pocket site.
  4. CAUTION: Avoid inadvertent puncture of the skin or fascia with the tip of the tunneler.
  5. d) Attach end of catheter onto the tunneler barb with a twisting motion.
  6. NOTE: Barb threads must be completely covered by the catheter to adequately secure the catheter as it is pulled through the tunnel. A suture may be tied around the catheter between the tunneler body and the large barb to hold it more securely.
  7. e) Pull the tunneler through to the port pocket site while gently holding the catheter.
  8. NOTE: The catheter must not be forced.
  9. f) Cut off end of the catheter attached to tunneler.

Connect Catheter to Port

1. Cleanse catheter with irrigation solution.

2. Prior to advancing the catheter lock, ensure that the catheter is properly positioned.

CAUTION: A catheter not advanced to the stem shoulder may not seat securely and lead to dislodgement and extravasation. The catheter must be straight with no sign of kinking. A slight pull on the catheter is sufficient to straighten it. Advancing the catheter lock over a kinked catheter may damage the catheter. Do not hold the catheter or cathlock with any instruments that could potentially damage either piece (e.g. hemostats).

3. Place catheter lock back onto catheter, ensuring the black radiopaque ring on the catheter lock faces away from the port body.

4. Cut the catheter to the proper length at a 90° angle, allowing sufficient slack for body movement and port connection. Check catheter for any damage. If any damage is noted, cut damaged section off before connecting catheter to port.

NOTE: Ensure that no guidewires or stiffening wires remain in the catheter lumen prior to cutting and adjusting catheter to desired length.

5. Align port stem with catheter.

NOTE: If the catheter and catheter lock are connected and then disconnected, the catheter end must be re-trimmed to ensure a secure re-connection.

NOTE: When using the catheter lock, be sure the end containing a colored radiopaque ring faces away from the port. The catheter lock should be sufficient to secure catheter to port.

NOTE: Sterile gauze may be used to facilitate stem to catheter connection.

Align port stem with catheter

6. Advance catheter over port stem to the shoulder (midway point).

NOTE: Advancing catheter too far along port stem could lead to “mushrooming” of tubing when the catheter lock is advanced. Should this occur, it is advisable to stop advancing the catheter lock, pull the catheter back along the stem away from the port, trim end of catheter and re-assemble the connection.

Advance catheter over port stem to the shoulder (midway point)

7. Advance catheter lock completely over the stem.

WARNING: Do not suture catheter to port, port stem, or surrounding tissue. Any damage or constriction of catheter may compromise power injection performance and catheter integrity. Bard does not recommend suturing around the catheter as doing so could compress, kink, or damage catheter, including catheter fragmenting and/or fracturing.

Advance catheter lock completely over the stem

Accessing the IV Port for Use: Preparing to Access the Port

Inspection and aseptic preparation of the access site should always be performed prior to accessing the port. Observe Universal Precautions on all patients.

1. Locate and identify the port via palpation with gloved hands. Place your finger on the high point of the port to identify the top of the funnel and palpate the funnel as it slopes down and away from this point. This area is the entrance to the port and should feel concave and hollow.

2. Collect and prepare the following equipment for use:

  • BD INSYTE™ AUTOGUARD™ Shielded IV Catheter, 16G or 14G, 1.75 inches (44 mm) or longer.
  • CAUTION: Use only non-hydrophilic IV catheters.
  • 10 mL or larger syringe filled with sterile normal saline
  • Primed extension set with clamps
  • Gloves
  • Masks
  • Additional items for cleaning and dressing the access site e.g. alcohol wipe, antiseptic swabs, gauze & dressings

3. Explain procedure to patient. Warn of needle stick sensation.

4. Wash hands thoroughly

5. Don sterile gloves

6. Cleanse or scrub the area according to the cleansing agent manufacturer’s instructions or institutional policy, as appropriate. An area of at least 10 – 13 cm (approximately 4 x 5 in.) diameter at the port insertion site is suggested.

Accessing the Port

1. Stabilize the port with non-dominant sterile gloved hand and palpate the funnel-shaped entrance.

2. Using a shallow angle of access, (approximately 30 degrees) relative to the skin, insert a 16G or 14G over-the-needle IV catheter into the funnel.

CAUTION: PowerFlow IV Port is not accessed with Huber non-coring needles. To access the PowerFlow IV Port, use BD INSYTE™ AUTOGUARD™ Shielded IV Catheters, 16G or 14G, 1.75 inches (44mm) or longer. The exact IV catheter length should be determined by the clinical situation.

CAUTION: Do not bend the needle while using the product.

3. Slide the needle to the stop at the center of the funnel where resistance will be felt.

Sliding Needle into Port

4. Slightly separate the needle from the IV catheter hub.

5. Pull the needle slightly away from the stop (approximately 5mm) to create space for catheter advancement.

6. Advance the IV catheter completely through the valve assembly, continuing to pull the needle slightly away, as needed.

NOTE: A minimum of 1.5 cm of catheter advancement past the stop is required to assure adequate passage through the valves.

Seperate the Needle from the IV Catheter Hub

NOTE: The risk of air aspiration is reduced by proceeding with this part of the procedure with the patient performing the Valsalva maneuver.

7. Once the IV catheter is in place, withdraw the needle and engage the needle safety mechanism.

CAUTION: For safety needles, if needle retraction does not occur, depress button again. Dispose of any unshielded needles immediately. Keep needlepoint away from body and fingers at all times.

Advance Catheter Through Port

8. Immediately attach syringe or extension set to the IV catheter.

CAUTION: The IV catheter hub should not be left open to air while it is in the port.

CAUTION: Do not reuse or reinsert the needle into the IV catheter. Reinsertion of the needle may cause damage to the IV catheter, which may lead to extravasation. Dispose of the needle according to hospital guidelines.

9. Aspirate to confirm the ability to draw blood. Flush with normal saline.

WARNING: Failure to confirm IV catheter placement may result in infiltration/extravasation.

WARNING: If high dose heparin (1,000 – 5,000 units/mL) is used, aspirate the solution out of the device before use to prevent systemic heparinization of the patient.

NOTE: Catheters used for apheresis procedures are larger bore catheters and require rapid flow rates. If used for apheresis, follow your facility’s apheresis protocol for flushing and locking after each apheresis procedure.

10. Securely dress insertion site and proceed with treatment protocol.

NOTE: Folded gauze used to support the catheter hub may help with optimizing flows. Check to ensure there are no kinks in the IV catheter at the skin line that may restrict flows.

NOTE: For continuous access, change IV catheter and transparent dressing every 72-96 hours, or when clinically indicated.

Deaccessing the Port

1. Following the treatment procedure, flush with normal saline.

2. Perform locking solution procedure and withdraw IV catheter while flushing continuously with locking solution.

NOTE: Maintaining positive pressure via continuous flush during IV withdrawal will help reduce potential for blood backflow into the catheter tip and possible catheter clotting.

CAUTION: Remember that some patients may be hyper-sensitive to heparin or suffer from heparin induced thrombocytopenia (HIT). These patients must not have their port locked with heparinized saline.

3. After IV catheter removal, apply pressure if bleeding occurs and apply dressing per hospital protocol.

Power Injection Procedure

1. Acces the PowerFlow IV Port with the BD INSYTE™ AUTOGUARD™ Shielded IV Catheter following the access steps in the section above. Make certain that the IV catheter is long enough to be inserted fully within the port and that the IV catheter has gone through the valve assembly.

WARNING: The port device is only power injectable when accessed with the BD INSYTE™ AUTOGUARD™ Shielded IV Catheter.

NOTE: Follow institutional protocol to verify correct catheter tip position prior to power injection.

2. Attach a syringe filled with sterile normal saline.

3. Instruct the patient to assume the position they will be in during the power injection procedure, before checking for patency. If possible, the patient should receive power injection with his or her arm vertically above the shoulder with the palm of the hand on the face of the gantry during injection. This allows for uninterrupted passage of injected contrast through the axillary and subclavian veins at the thoracic outlet.

4. Aspirate for adequate blood return and vigorously flush the port with at least 10 mL of sterile normal saline.

WARNING: Failure to ensure patency of the catheter prior to power injection studies may result in port system failure.

5. Detach syringe.

6. Warm contrast media to body temperature.

7. Attach the power injection device to the power injection rated IV catheter ensuring connection is secure.

Check indicated flow rate of power injection rated IV catheter and confirm power injector settings.

WARNING: Do not exceed a 300 psi pressure limit setting on the power injection machine, or the maximum recommended flow rate on the IV catheter, if power injecting through the PowerFlow IV Port (max infusion rate is 5mL/s).

NOTE: Refer to packaging insert for power injection information.

8. Instruct the patient to communicate immediately any pain or change in feeling during the injection.

9. Inject contrast media warmed to body temperature, taking care not to exceed the flow rate limits.

WARNING: If local pain, swelling or signs of extravasation are noted, the injection should be stopped immediately.

WARNING: Exceeding the maximum flow rate may result in port system failure.

10. Disconnect the power injection device.

11. After therapy completion, flush the port per institutional protocol. Withdraw IV catheter while flushing continuously with locking solution.

12. Perform locking procedure.

CAUTION: Remember that some patients may be hyper-sensitive to heparin or suffer from heparin induced thrombocytopenia (HIT). These patients must not have their port locked with heparinized saline.

NOTE: The PowerFlow IV Port testing included at least 36 power injection cycles with a power injection rated IV catheter and 11.8 cP viscosity contrast solution.

Determining Port System Volumes for Port Lock Procedures

For port system volumes, please refer to the packaging insert.

Locking Solution Procedure

To help prevent clot formation and catheter blockage, the port’s open-ended catheter should be filled with sterile locking solution after each use. If the port remains unused for long periods of time, the locking solution should be changed at least once every four weeks.

CAUTION: Remember that some patients may be hyper-sensitive to heparin or suffer from heparin induced thrombocytopenia (HIT). These patients must not have their port locked with heparinized saline. If the port catheter length is not known, refer to the packaging insert for recommended flushing volumes for open-ended catheters, otherwise follow institutional protocol.

Equipment

  • BD INSYTE™ AUTOGUARD™ Shielded IV Catheter, 16G or 14G, 1.75 inches (44mm) or longer.
  • 10 mL syringe filled with sterile saline
  • 10 mL syringe filled with 5 mL locking solution (100 U/mL)

NOTE: Concentrations of heparinized saline (10 to 1000 U/mL) have been found to be effective.

Determination of proper concentration and volume should be based on patient’s medical condition, laboratory tests, and prior experience. Follow your facility protocol for heparin concentrations for apheresis catheters.

Procedure

1. Explain procedure to patient and prepare injection site.

2. Aseptically locate and access port.

3. Attach a 10 mL syringe filled with sterile normal saline to IV catheter.

4. After therapy completion, flush port per institutional protocol, then lock with 5 mL 100 U/mL locking solution, or with port system volume calculated on package insert. Withdraw IV catheter while flushing continuously with locking solution.

WARNING: Alcohol should not be used to soak, declot or lock the device or polyurethane catheters because alcohol is known to degrade the product materials over time with repeated and prolonged exposure.

MRI Safety Information

MR Icon

MR Conditional

Non-clinical testing has demonstrated that the device is “MR conditional”. A patient with this device can be safely scanned in an MR system meeting the following conditions immediately after placement:

Static Magnetic Field

  • Static Magnetic Field of 3 Tesla (T) or less
  • Maximum spatial gradient magnetic field of 3,000 Gauss/cm or less
  • Maximum MR system reported, whole body average specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)

Under the scan conditions defined above, the Bard PowerFlow Apheresis IV Port is expected to produce a maximum temperature rise of less than 6.0° C after 15 minutes of continuous scanning.

CAUTION: RF heating behavior for the Bard PowerFlow Apheresis IV Port does not scale with static field strengths and has not been evaluated with static field strengths above 3 T.

ARTIFACT INFORMATION

In non-clinical testing, the image artifact caused by the device extends approximately 14 mm from the Bard PowerFlow Apheresis IV Port when imaged with a gradient-echo pulse sequence in a 3 T MRI system.

References

1. Jacobs, D. M. et. al., “Anatomical and Morphological Evaluation of Pacemaker Lead Compression”. PACE. 1993 Mar; 16(1):434-444.

2. Magney, J. E. et. al., “Anatomical Mechanisms Explaining Damage to Pacemaker Leads, Defibrillator Leads and Failure of Central Venous Catheters Adjacent to the Stemoclavicular Joint”. PACE. 1993 Mar; 16(1):445-457.

3. Hinke, D,H.; Zandt-Stastny, D.A.; Goodman, L.R.; et.al. Pinch-off syndrome: A complication of implantable subclavian venous access devices. Radiology 177:353-356, 1990.

4. Ingle, Rebecca; Nace, Corinne. “Venous Access Devices: Catheter Pinch-off and Fracture”. 1993, Bard Access Systems, Inc.

5. Camp-Sorrell, Dawn. “Access Device Guidelines.” 3rd Ed. Oncology Nursing Society, 2011.

Further Reading

See PowerFlow Implantable Apheresis IV Port Nursing Guide and/or PowerFlow Implantable Apheresis IV Port CT Guide for more details.

See Bard Peripheral Vascular’s Sales Representative for more information about any of these products. An issued or revision date for these instructions is included for the user’s information. In the event two years have elapsed between this date and product use, the user should contact Bard Peripheral Vascular, Inc. to see if additional product information is available.

Revised Date: April 2017.

NOT MADE WITH NATURAL RUBBER LATEX

Manufacturer:
Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 USA
800-545-0890
801-522-5000

 

Clinical Information Hotline:
800-555-7422
www.bardpv.com

 

Bard, PowerFlow and the radiopaque symbol are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners. Copyright © 2017 C. R. Bard, Inc. All Rights Reserved.