Medtronic 8540 Instructions for Use

Catheter Access Port Kits 8540

for use with Medtronic Implantable Infusion Pumps

8543

Instructions for Use

  Rx only

1993 (8540)
1997 (8543)

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

EC

! USA

XXX °F

LOT

REP

EO

Consult instructions for use

Use by

Date of manufacture

Manufacturer

XX °C

Temperature limitation

Lot number

Authorized representative in the European community

Volume

Conformité Européenne (European Conformity).
This symbol means that the device fully complies with
European Directive AIMD 90/385/EEC.

For USA audiences only

STERILE

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

MiniMed® is a registered trademark of Medtronic MiniMed, Inc.

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Table of contents

Introduction 7

Package contents 7

Indications 7

Contraindications 7

Warnings 7

Precautions 9

Adverse events 11

Instructions for Use 11

Preliminary procedures 11
Preparing the access site 11
Intraspinal applications only 12
Vascular applications only 13
Flushing the catheter access port 14
Clearing a catheter occlusion 14

Technical support 15

Emergency procedures 16

Baclofen injection overdose 16
Baclofen injection underdose/withdrawal 18
Morphine intrathecal/epidural overdose 20
Emergency procedure to empty pump reservoir 22

Special notice 23

Limited Warranty 24

Medtronic® Neuromodulation MODEL 8540 AND MODEL 8543
CATHETER ACCESS PORT KITS LIMITED WARRANTY (U.S.
Customers Only) 24

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 8540 Catheter Access Port Kit (CAP kit) contains the following
sterile components that are not made with natural rubber latex:

Extension set with a clamp

▪

0.22-micron filter

▪

24-gauge noncoring needles with purple color (2)

▪

25-gauge noncoring needles with orange color (2)

▪

10-mL syringe

▪

Fenestrated drape

▪

Template (2)

▪

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

▪

0.22-micron filter

▪

24-gauge noncoring needles with purple color (2)

▪

10-mL syringe

▪

Fenestrated drape

▪

Template (1)

▪

Indications

The Model 8540 Catheter Access Port Kit is intended for use in accessing the
catheter via the catheter access port of Medtronic implantable programmable
infusion pumps (except Medtronic MiniMed pumps).

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. Blood sampling through the catheter access port is
contraindicated. Blood sampling can occlude the catheter or pump, inhibiting
drug delivery and requiring surgical revision or replacement.

Warnings

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

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

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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 (intraspinal applications) - During intraspinal
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.

Catheter aspiration (vascular applications) - During vascular applications,
do not aspirate blood through the catheter access port or catheter. Blood
sampling or aspiration through the catheter access port is contraindicated in
vascular applications. Residual blood from aspiration or blood sampling can
occlude the catheter or pump and inhibit drug delivery, resulting in a 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, and
require surgical revision or replacement.

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.

Contrast medium - When injecting contrast medium into the intraspinal
space, use ONLY contrast medium indicated for intraspinal use. Using
nonindicated contrast media can result in adverse events including, but not
limited to, extreme pain, cramps, seizures, and death. Inject contrast medium
through the catheter access port only.

Drug information - Refer to the appropriate drug labeling for indications,
contraindications, warnings, precautions, dosage and administration
information, and screening procedures. Refer to the appropriate drug labeling
for specific drug underdose or overdose symptoms and methods of
management. Failure to refer to the drug labeling can result in inappropriate
patient selection and management, inadequate therapy, intolerable side
effects, or a clinically significant or fatal drug underdose or overdose. Consider
the possibility of a drug error if the patient experiences unusual side effects.
Failure to do so can result in misdiagnosis of patient symptoms.

Drug interaction and side effects - Inform patients of the appropriate
warnings and precautions regarding drug interactions, potential side effects,
and signs and symptoms that require medical attention, including prodromal
signs and symptoms of inflammatory mass. Failure to recognize the signs and
symptoms and to seek appropriate medical intervention can result in serious
patient injury or death.

Drug overdose symptoms and management - Refer to the emergency
procedures included at the end of this manual and the appropriate drug
labeling for specific drug overdose symptoms and methods of management.

Drug underdose/overdose - Inform patients and caregivers of the signs and
symptoms of a drug underdose and overdose. Inform patients and caregivers:

to be aware and report any unusual signs or symptoms at any time

▪

during or after a refill or catheter access port procedure.
to be alert for any burning sensations in the area of the pump pocket

▪

during their refill or catheter access port procedure.
to especially watch for signs of underdose and overdose.

▪

to stay alert for signs or symptoms that may indicate changes to their

▪

prescribed drug concentration or programmed dose.
to seek emergency assistance as necessary. Refer to the refill kit or

▪

CAP kit manual or the Indications, Drug Stability and Emergency
Procedures for SynchroMed and IsoMed Implantable Infusion
Systems Reference Manual for emergency procedures associated
with drug underdose and overdose.

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Failure to recognize these signs and symptoms and to seek appropriate
medical intervention can result in serious patient injury or death.

Implantation and system management - Implantation and ongoing system
management must be performed by individuals trained in the operation and
handling of the infusion system and must be in compliance with procedures
described in the appropriate technical instructions. Inadequate training or
failure to follow instructions can require surgical revision or replacement, and
result in a clinically significant or fatal drug underdose or overdose.

Injection error during a catheter access port procedure - Be certain you
are accessing the correct port when injecting fluids into the catheter access
port of an implanted pump. ALWAYS:

identify the pump model.

▪

identify the location of the catheter access port.

▪

use the instructions, noncoring needles, appropriate template, and

▪

other accessories provided in the appropriate kit.
verify the location of the correct port during needle insertion according

▪

to the instructions provided AND using other medical procedures as
appropriate.

refer to the appropriate drug labeling for indications, contraindications,

▪

warnings, precautions, adverse events, and dosage and

administration information.
Pocket fill is the improper injection into the subcutaneous tissue, which
includes the pump pocket, during a catheter access port injection.
Pocket fill can result in significant tissue damage or a loss of or change
in symptom control, drug withdrawal symptoms, or a clinically significant
or fatal drug underdose or overdose. Observe the patient after the
catheter access port injection for any signs or symptoms that could
indicate a pocket fill or any other drug-related adverse event. Seek
emergency assistance as necessary. Refer to the CAP kit manual or
the Indications, Drug Stability and Emergency Procedures for
SynchroMed and IsoMed Implantable Infusion Systems Reference
Manual for emergency procedures associated with drug underdose and
overdose.

Inadvertent injection into the reservoir fill port can result in changes
to the drug concentration and drug content in the pump reservoir,
resulting in a clinically significant or fatal drug underdose or overdose.
Injection of fluids such as contrast media into the reservoir fill port may
result in permanent system damage leading to a clinically significant or
fatal drug underdose or overdose.

Intraspinal therapy - For intraspinal therapy, use ONLY a preservative-free
sterile solution indicated for intraspinal use. Nonindicated fluids containing
preservatives or endotoxins can be neurotoxic in intraspinal applications.
Using nonindicated fluids can result in adverse events including, but not
limited to, extreme pain, cramps, seizures, and death.

User instructions - Comply with all product instructions for initial preparation
and filling, implantation, programming (if applicable), refilling, and accessing
the catheter access port (if present) of the pump. Failure to comply with all
instructions can lead to technical errors or improper use of implanted infusion
pumps and result in additional surgical procedures, a return of underlying
symptoms, drug withdrawal symptoms, or a clinically significant or fatal drug
underdose or overdose.

Precautions

Aseptic technique - Use strict aseptic technique when accessing the

reservoir fill port or the catheter access port of an implanted pump. Failure to
use aseptic technique can contaminate fluids or tissues and result in local or
systemic infection.

Catheter access port filter - Always use a bacterial-retentive filter when
injecting through the catheter access port. The catheter access port does not
contain a filter. Injecting into the catheter without using a filter can
contaminate fluids or tissues and result in local or systemic infection.

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