Medtronic 8551 Instructions for Use

Refill Kit 8551
for use with Medtronic Implantable Programmable 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

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

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

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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

Description 7

Package contents 7

Intended Use 7

Indications 7

Contraindications 7

Warnings 7

Precautions 10

Adverse events 11

Instructions for use 12

Sterilization 12
Preliminary procedures 12
Emptying the SynchroMed pump 13
Refilling the SynchroMed pump 16
Programming the SynchroMed pump 19
After the refill procedure 19

Reservoir rinse procedure 19

Performing a reservoir rinse 19

Technical support 20

Emergency procedures 21

Baclofen injection overdose 21
Baclofen injection underdose/withdrawal 23
Morphine overdose 25
Emergency procedure to empty pump reservoir 26

Special notice 27

Limited Warranty 28

Medtronic® Neuromodulation MODEL 8551 REFILL KIT LIMITED
WARRANTY (U.S. Customers Only) 28

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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Description

These instructions include only the procedure for refilling the pump reservoir.
Refer to the appropriate pump technical manual for implanting instructions.

Package contents

The Model 8551 Refill Kit contains the following sterile components that are
not made with natural rubber latex:

20-mL syringe

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Extension tubing and clamp

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Two 22-gauge non-coring needles

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Template

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0.2-micron filter

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Fenestrated drape

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Intended Use

The Model 8551 Refill Kit is intended for use in refilling Medtronic implantable
programmable infusion pumps with the exception of Medtronic MiniMed
infusion pumps.

Indications

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

Contraindications

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

Warnings

User instructions - Comply with all product instructions for initial preparation

and filling, implantation, programming, 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.

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.

Overinfusion - Overinfusion is defined as the delivery of more drug volume
than the programmed rate, exceeding the pump’s flow rate accuracy
specification. Pump reservoir contents aspirated during a refill procedure that
are less than expected may indicate that the pump has overinfused.
Overinfusion may or may not be associated with clinically relevant symptoms.
When the pump delivers more drug volume than the programmed rate,
patients may experience overdose symptoms, and the pump reservoir will
deplete more quickly than expected. Patients may experience underdose or
withdrawal symptoms if the drug is depleted prior to the scheduled refill date
from an overinfusing pump. At each refill visit, question and examine the
patient for signs and symptoms of overdose, underdose, and withdrawal.

The low reservoir alarm of an overinfusing pump will not sound if the
pump reservoir is prematurely depleted. The low reservoir alarm is

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calculated from the pump’s programmed delivery rate and is not a direct
measurement of the actual drug volume in the pump reservoir. Multiple factors
may increase the likelihood of overinfusion, including: nonindicated drug
formulations, overfilling of the pump reservoir, operation of the pump with no
fluid in the reservoir, catheter occlusion, and pump stops or motor stalls
lasting more than 48 hours.

Refer to the appropriate drug labeling for specific drug underdose or overdose
symptoms and methods of management. If overinfusion is strongly suspected,
contact Medtronic. Reducing the dose and/or concentration is not
recommended as a solution for overinfusion. If immediate discontinuation of
therapy is clinically appropriate for the patient, program the pump to minimum
rate mode, and aspirate any remaining drug from the reservoir. Five
occurrences of overinfusion have been identified in Medtronic’s prospective,
long-term multi-center registry study (Product Surveillance Registry) as of
January 2016, resulting in a rate estimate of less than 0.14% (approximately 1
in 700).

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.

Contrast medium (pumps with a catheter access port) - Do not inject any
contrast medium into the pump reservoir. Injecting contrast medium into the
pump reservoir can impair pump operation.

Refill - Patients must return to the clinic for refills at the prescribed times.
Failure to return to the clinic for refills at the prescribed times can result in the
actual flow rate of the pump being less than expected, 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.
Failure to return at the prescribed times can also damage the pump, requiring
surgical replacement.

Refill kit components - Use the appropriate Medtronic refill kit during all refill
procedures for Medtronic implantable infusion pumps. Using components
other than Medtronic components or a kit other than the appropriate refill 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 or overdose.

Injection error during a pump refill procedure - Be certain you are
accessing the reservoir fill port when injecting fluids into an implanted pump.
ALWAYS:

identify the pump model and reservoir volume.

▪

identify the location of the reservoir fill port.

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use the instructions, noncoring needles, appropriate template edge,

▪

and other accessories provided in the appropriate kit.
verify the location of the reservoir fill port during needle insertion

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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. 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 pump refill procedure for any signs or
symptoms that could indicate a pocket fill or any other drug-related
adverse event due to the refill procedure. Seek emergency assistance
as necessary. Refer to the refill kit manual or the indications, drug

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stability and emergency procedures manual for emergency procedures
associated with drug underdose and overdose.

Inadvertent injection into the catheter access port may result in a
clinically significant or fatal drug overdose. Observe the patient after the
pump refill procedure for any signs or symptoms that could indicate a
drug-related adverse event due to the pump refill procedure.

Pocket fill - If it is suspected or known that all or part of the drug was injected
into the pocket during the refill procedure, monitor the patient closely for signs
and symptoms of overdose in an appropriate facility for a sufficient amount of
time or until the symptoms have resolved. Refer to “Emergency Procedures”
in the indications, drug stability, and emergency procedures manual, the refill
instructions for use, and the appropriate drug labeling for specific drug
underdose and overdose symptoms and methods of management.

Changing drug or decreasing drug concentrations - Rinse the reservoir
twice between solutions when changing drug or decreasing drug
concentrations in the pump reservoir. A significant amount of drug may be
present in the pump reservoir after emptying the pump. This residual volume
cannot be removed by emptying the pump. Rinsing the reservoir between
solutions minimizes the amount of drug in this residual volume but does not
eliminate it. Failure to account for residual drug in the pump reservoir can
result in a concentration that is different than intended and a clinically
significant or fatal drug underdose or overdose. Program a bridge bolus after
rinsing the reservoir twice.The bridge bolus advances the remaining old drug
(the drug left in the pump tubing, catheter access port, and catheter after
emptying and refilling the pump) to the catheter tip at the specified flow rate.

Refer to "Performing a reservoir rinse" on page 19 of this manual. Refer to
the programming guide for bridge bolus procedures.

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.

Reservoir fill port injections - Do not use excessive force when accessing
the reservoir fill port. Excessive force can result in damage to the needle or
pump requiring surgical revision or replacement, and 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 or overdose.

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

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 incompatibility - Medtronic implantable infusion systems are only
approved for use with specific drugs. Do not use:

drugs or fluids that may contain preservatives, antimicrobials, or

▪

antioxidants or that exhibit chemical properties (such as pH ≤3) that
are not compatible with the infusion system.

drugs or fluids that may break down over time and produce

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degradation products that are not compatible with the infusion system
(eg, diamorphine and diacetylmorphine).

drugs or drug mixtures that may precipitate in the pump and inhibit

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pump flow or occlude the catheter (eg, greater than approved
concentrations).

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