Medtronic 8540 Instructions for Use

Catheter Access Port Kit 8540
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

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

REF

STERILIZE

Do not use if package is damaged

Reorder number

Do not resterilize

2

 2018-03-01  English 3

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

®

MiniMed

is a registered trademark of Medtronic MiniMed, Inc.

4 English  2018-03-01

Table of contents

Description 7

Package contents 7

Intended Use 7

Indications 7

Contraindications 7

Warnings 7

Precautions 9

Adverse events 10

Instructions for Use 10

Preliminary procedures 10
Preparing the access site 11
Using the catheter access port 11
Flushing the catheter access port 12

Technical support 13

Emergency procedures 14

Baclofen injection overdose 14
Baclofen injection underdose/withdrawal 16
Morphine overdose 18
Emergency procedure to empty pump reservoir 20

Special notice 21

Limited Warranty 22

Medtronic® Neuromodulation MODEL 8540 CATHETER ACCESS PORT
KIT LIMITED WARRANTY (U.S. Customers Only) 22

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.

 2018-03-01  English 5

6 English  2018-03-01

Description

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 tubing and clamp

▪

0.2-micron filter

▪

24-gauge non-coring needles with purple color (2)

▪

10-mL syringe

▪

Fenestrated drape

▪

Template

▪

Intended Use

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).

Indications

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

Contraindications

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

Warnings

Advancing drug to catheter tip - 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 - Use the appropriate Medtronic
catheter access port kit 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 - Before injecting fluids through the catheter access port,
aspirate approximately 1 to 2 mL from the catheter. A significant amount of
drug may be present in the catheter access port and catheter, and failure to

 2018-03-01  English 7

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.

Contrast medium - When injecting contrast medium into the intrathecal
space, use ONLY contrast medium indicated for intrathecal 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. For emergency

▪

procedures associated with drug underdose and overdose, refer to the
refill kit or catheter access port kit manual or the indications, drug
stability and emergency procedures manual.

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.

8 English  2018-03-01