PowerFlow® Implantable Apheresis IV Port Safety Information

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.

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.