Medtronic 8543 Instructions for Use

Catheter Access Port Kit 8543
for use with Medtronic Implantable Infusion Pumps

Instructions for Use

Rx only

Explanation of symbols on product or package labeling

Refer to the appropriate product for symbols that apply.

Open here

Do not reuse

Sterilized using ethylene oxide

-XX °C

-XX °F

XXX °F

LOT

EO

Consult instructions for use

Use by

Date of manufacture

XX °C

Temperature limitation

Lot number

Volume

STERILE

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Medtronic, IsoMed, and Medtronic logo are trademarks of Medtronic.

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Table of contents

Introduction 7

Package contents 7

Indications 7

Contraindications 7

Warnings 7

Precautions 9

Adverse events 10

Instructions for Use 10

Preliminary procedures 10
Preparing the access site 10
Intrathecal applications only 11
Flushing the catheter access port 12

Technical support 13

Emergency procedures 14

Morphine intrathecal overdose 14
Emergency procedure to empty pump reservoir 16

Special notice 17

Limited Warranty 18

Medtronic® Neuromodulation MODEL 8543 CATHETER ACCESS PORT
KITS LIMITED WARRANTY (U.S. Customers Only) 18

Refer to the indications, drug stability, and emergency procedures
reference manual for indications and related information.

Refer to the appropriate information for prescribers booklet for
contraindications, warnings, precautions, adverse events summary,
individualization of treatment, patient selection, use in specific
populations, and component disposal.

Refer to the appropriate drug labeling for indications,
contraindications, warnings, precautions, dosage and administration
information, and screening procedures.

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Introduction

These instructions include only the procedure for accessing the catheter via
the catheter access port. Refer to the appropriate pump technical manual for
implanting instructions and pump indications, contraindications, warnings,
precautions, and adverse events.

Package contents

The Model 8543 Catheter Access Port Kit (CAP kit) contains the following
sterile components that are not made with natural rubber latex:

Extension set with a clamp

▪

0.2-micron filter

▪

24-gauge noncoring needles with purple color (2)

▪

10-mL syringe

▪

Fenestrated drape

▪

Template (1)

▪

Indications

The Model 8543 Catheter Access Port Kit is intended for use in accessing the
catheter via the catheter access port of Medtronic implantable IsoMed pumps.

Contraindications

Medtronic catheter access port kits are contraindicated for all refill
procedures.

Warnings

Advancing drug to catheter tip (intrathecal applications) - For intrathecal

applications, do not inject drug directly into the catheter or through the
catheter access port to advance drug to the catheter tip. Injecting through the
catheter access port or injecting directly into the catheter to advance drug to
the catheter tip can result in a clinically significant or fatal drug overdose.

Calculating catheter volume - Use the catheter length recorded at implant
or catheter revision when calculating catheter volume. The actual implanted
catheter length and catheter model number are required to accurately
calculate catheter volume. A universal value does not exist that can be used
as a substitute for this knowledge. An inaccurate catheter volume calculation
can result in a clinically significant or fatal drug underdose or overdose.

Catheter access port kit components - The appropriate Medtronic catheter
access port kit MUST be used during all catheter access port procedures for
Medtronic implantable infusion pumps. Using components other than
Medtronic components or a kit other than the appropriate catheter access
port kit can damage Medtronic components, requiring surgical revision or
replacement, and allow drug leakage into surrounding tissue, resulting in
tissue damage or loss of or change in therapy, which may lead to a return of
underlying symptoms, drug withdrawal symptoms, or a clinically significant or
fatal drug underdose.

Catheter aspiration (intrathecal applications) - During intrathecal
applications, before injecting fluids through the catheter access port, aspirate
approximately 1 to 2 mL from the catheter (unless contraindicated). A
significant amount of drug may be present in the catheter access port and
catheter, and failure to remove the drug during catheter access port injections
can result in a clinically significant or fatal drug overdose.

Connections - Firmly secure all connections. Failure to secure connections
can allow drug to leak onto the surrounding skin and may result in inadequate
therapy or infection.

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