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™ 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.
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.
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.
This device is contraindicated for:
I. Prior to Placement
II. During Placement
III. After Placement:
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:
These and other complications are well documented in medical literature and should be carefully considered before placing the port.
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.
Difficulty with blood withdrawal
1. Select the pocket site for port placement.
NOTE: Port pocket site selection should allow for port placement in an anatomic area that:
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.
1. Locate and access vessel with introducer needle attached to a syringe.
NOTE: Vessel location may be facilitated using imaging guidance.
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.
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.
4. If using a micropuncture set,
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.
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.
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.
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.
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.
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.
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.
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. 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.
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.
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.
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:
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.
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.
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.
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.
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.
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.
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.
For port system volumes, please refer to the packaging insert.
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.
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.
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.
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:
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.
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.
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.
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
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