Indications, safety and warnings for Intera

The Intera 3000 Hepatic Artery Infusion Pump is used to deliver medications such as chemotherapy to the blood vessels in the liver.

With all medical procedures, there are risks associated with the procedure to place the pump in your abdomen and with the use of the pump to deliver medications. The risks associated with placement and use of the pump include but are not limited to bleeding, blood clots, blockage within the device, damage to the blood vessels, fluid or blood build-up around the device under the skin, infection, movement or displacement of the pump or catheter, pump damage, and leakage or incorrect delivery of the medications.

Special care may be required after placement of the Intera 3000 Pump and includes but is not limited to avoiding rough physical activity, avoiding deep sea or scuba diving, avoiding saunas, avoiding long periods in hot tubs and avoiding direct sun exposure, heating pads or hot water bottles over the area of your abdomen where the pump is placed. Additional care may be needed for air travel, moving to or visiting a high-altitude place, or if you have a fever.

The Intera 3000 Pump is MRI Conditional, which means that certain conditions must be met to safely have an MRI after placement of the pump.  

 Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the use of the device.

The Intera 3000 Refill Kit is indicated for use with the Intera implanted infusion pumps to administer infusate solutions.

The Refill Kit is indicated for emptying and refilling the reservoir of an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump.

For Indications for Use of the Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump, please find a digital copy of the associated IFU at: www.interaoncology.com/providers/resource-library/usa-library

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The pump must be implanted and refilled only by qualified medical personnel, knowledgeable in the surgical use and servicing of implantable devices and catheters, and trained specifically to implant or refill the pump. Use of the pump by personnel not properly trained in its implantation and/or servicing can lead to serious consequences involving either under or over-delivery of drug to the patient. In the event of an over delivery of drug refer to the approved drug labeling for appropriate action.

Utilization of the pump requires the proper handling (filling, storage and dispensing) of a significant volume/dosage of drug. This amount of drug can be extremely harmful to the patient if delivered suddenly or inappropriately.

Bolus access and pump refill procedures must be performed using the correct access needle. Never attempt to refill the pump using a Special Bolus Needle. This use will result in giving a bolus injection to the patient and can cause a fatal drug overdose.

The INTERA 3000 Hepatic Artery Infusion Pump contains a safety valve in-line with the bolus pathway to insure that a bolus procedure can only be performed when using a properly positioned Special Bolus Needle (REF AP-040135 or AP-040325).

CAUTION: Inspect the sterile package carefully. Do not use if:

• the package or seal appears damaged,
• contents appear damaged, or
• the expiry date has passed.

A needle is provided in this kit. It is critical to the safe functioning of the pump that no other needle be used to penetrate the septum.

Do not aspirate fluid through the Bolus Pathway. Aspiration will cause blood to be drawn into catheter and result in occlusion.

It is important to precisely follow the Pump Refill Instructions as detailed in this pamphlet in order to successfully complete the pump refill procedure. If the needle is not properly positioned, and verified as detailed in the Pump Refill Procedures, there is a possibility that a drug extravasation will occur.

If the patient is traveling to a different altitude during the refill interval, refer to Flow Rate Graphs for flow rate adjustment.

If the refill is using glycerin, refer to the Intera Glycerin IFU, available at www.interaoncology.com

PRECAUTION: If no fluid returns to the syringe upon release of the plunger, DO NOT CONTINUE TO INJECT REFILL SOLUTION UNTIL YOU HAVE VERIFIED THE NEEDLE PLACEMENT PER THE PROCEDURE IN THE TROUBLESHOOTING GUIDE. Follow steps A, B, C, D per the Troubleshooting Guide.

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The Non-coring (Huber) Refill Needles are indicated for use with the Intera implanted infusion pumps to administer infusate solutions.

The Refill Needles are indicated for emptying and refilling the reservoir of an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump.

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• This product is provided sterile and is intended for single use only. Do not resterilize or reuse as this could compromise device performance and patient safety.
• Inspect the package carefully before use. Do not use if:
  • The package or seal appears damaged as sterility can no longer be assured.
  • The contents appear damaged as proper operation can no longer be assured.
  • The “use by” date has passed as package and product integrity can no longer be assured.
• Use sterile technique in all phases of handling this product to maintain sterility.
• Use Refill Needles only for draining and refilling the reservoir of an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump.

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The Intera Non-coring (Huber) Special Bolus Needles are indicated for use with the Intera implanted infusion pumps to administer infusate solutions.

The Special Bolus Needles are indicated for delivering bolus injections or infusions through an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump.

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• NEVER attempt to REFILL the Pump using a SPECIAL BOLUS NEEDLE. This use will result in giving a bolus injection to the patient and may cause a drug overdose.
• This product is provided sterile and is intended for single use only. Do not resterilize or reuse as this could compromise device performance and patient safety.
• Inspect the package carefully before use. Do not use if:
  • The package or seal appears damaged as sterility can no longer be assured.
  • The contents appear damaged as proper operation can no longer be assured.
  • The “use by” date has passed as package and product integrity can no longer be assured.
• Use sterile technique in all phases of handling this product to maintain sterility.
• Use Special Bolus Needles only for delivering bolus injections or infusions through an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump
• SPECIAL BOLUS NEEDLE is not intended for use with Implantable Ports. The Special Bolus Needle has egress is on the side of the cannula rather than the tip.

• Before performing a bolus injection of any drug, review all warnings, precautions, indications and contraindications on the drug labeling.
• Use only a SPECIAL BOLUS NEEDLE for performing a bolus procedure.
• Do not aspirate fluid/blood back through the bolus path as catheter occlusion may result.
• Do not use a mechanical pressure injector system to accomplish a bolus procedure. Pressure should not exceed 40 psi when administering a bolus injection or infusion. For injections use only 10 mL (or larger) syringes and do not inject or infuse at a rate greater than 5 mL/min.

PRECAUTION: When the systems is flushed with saline the patient will receive a bolus dose of drug equal to the volume of drug contained in the internal bolus pathway of the Pump, plus the volume of drug in the catheter. The volume of drug in the internal pathway of the pump is shown below. The volume of drug contained in the catheter can be calculated by multiplying the length (in cm) of the catheter utilized, by the volume of the fluid contained per cm of catheter.

PRECAUTION: The patient should remain still throughout this procedure to prevent any movement of the SPECIAL BOLUS NEEDLE. If the needle is withdrawn during the procedure, the bolus safety valve will close and it will not be possible to accomplish this procedure. If the needle is withdrawn an amount exposing the lumen above the upper septum of the Pump, a drug extravasation may occur.

CAUTION: A) Always use preservative free saline for flush solution with pumps that access the intrathecal or intraspinal spaces.

      B) If more than one drug is administered, flush set and pump with saline between drugs.

      C) SPECIAL BOLUS NEEDLE is intended for single use only. DO NOT RESTERILIZE.

      D) As with all conventional (PVC) administration sets, this device should be used in compliance with the drug/solution labeling.

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Glycerin infusion is indicated for patients who are receiving continuous Hepatic Arterial FUdR Chemotherapy. Glycerin infusion is employed as a placebo to keep the catheter patent or to extend the refill interval for patients who require therapy interruption or withdrawal:

Infusate

• Glycerin injection

Indicated Route of Administration

• Arterial

Glycerin Injection is not intended for intraspinal delivery in INTERA 3000 Hepatic Artery Infusion Pumps with Bolus Safety Valve. Glycerin Infusion is not intended for use with any drugs or therapeutic agents other than FUdR.

The compounding of Glycerin Injection shall be in accordance with all applicable state and federal laws. Glycerin Injection should be compounded with Glycerin USP for high risk injections as defined in USP<1206>, including appropriate testing for sterility, bacterial endotoxins, and subvisible particulates. The compounded Glycerin Injection should comply with USP <1> Injections.

The Pump should be refilled only by qualified medical personnel, knowledgeable in the servicing of implant-able devices and catheters, and trained specifically to refill the Pump. Use of the Pump by personnel not properly trained in its servicing may lead to serious consequences involving either under- or over-delivery of drug to the patient. In the event of an over-delivery of drug, refer to the approved drug labeling for appropriate action. Glycerin Injection is not intended for intraspinal delivery.

Utilization of the Pump requires the proper handling (filling, storage and dispensing) of a significant volume/dosage of drug. This amount of drug may be extremely harmful to the patient if delivered suddenly or inappropriately.

Bolus access and refill procedures must be performed using the correct access needle. Never attempt to refill the Pump using a Special Bolus Needle. This use will result in giving a bolus injection to the patient and may cause a fatal drug overdose.

Bolus Pathway Flush

WARNING: NEVER attempt to REFILL the Pump using an INTERA SPECIAL BOLUS NEEDLE. This use will result in giving a bolus injection to the patient and may cause a fatal drug overdose.

Hemolysis from Glycerin Infusion has been reported in the literature. The risk and degree of hemolysis from Glycerin Infusion when used as intended with implantable pumps are unknown. Testing for hemolysis should be considered.

CAUTION: Use recommended personal protection for handling chemotherapeutic agents. Recommended reference: Oncological Nurses Society for Chemotherapy Administration.

CAUTION: Review Material Safety Data Sheets for Floxuridine (or any hazardous chemicals) to determine the required level of protection

PRECAUTION: If no fluid returns to the syringe upon release of the plunger, DO NOT CONTINUE TO INJECT REFILL SOLUTION UNTIL YOU HAVE VERIFIED THE NEEDLE PLACEMENT PER THE PROCEDURE IN THE TROUBLE-SHOOTING GUIDE. Follow steps A, B, C, D per the Troubleshooting Guide.

Bolus Pathway Flush

PRECAUTION: 1) Before performing a bolus injection of any drug, review all warnings, precautions, indications and contraindications on the drug labeling.

PRECAUTION: 2) Use only an INTERA SPECIAL BOLUS NEEDLE for performing a bolus procedure.

PRECAUTION: 3) Do not aspirate fluid/blood back through the bolus path as a catheter occlusion may result.

PRECAUTION: 4) Do not use a mechanical pressure injector system to accomplish a bolus procedure. Pressures should not exceed 40 psi when administering a bolus injection or infusion. For injections use only 10 mL (or larger) syringes and do not inject or infuse at a rate greater than 5 mL/minute.

PRECAUTION: When the system is flushed with saline, the patient will receive a bolus dose of drug equal to the volume of drug contained in the internal bolus pathway of the Pump (refer to *Bolus Table), plus the volume of the drug in the catheter. The volume of the drug in the internal pathway of the Pump and the volume of the drug contained in the catheter, can be calculated by multiplying the length (in cm) of the catheter utilized by the volume of fluid contained per cm of catheter. Please refer to the table below.

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