Medtronic 8553 Instructions for Use

Refill Kit
for use with Medtronic IsoMed Pumps

8553

Instructions for Use

Rx only

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Medtronic®, IsoMed®, and SynchroMed® are trademarks of Medtronic, Inc.,
registered in the U.S. and possibly other countries.

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Table of contents

Introduction 5

Package contents 5

Indications 5

Contraindications 5

Warnings 5

Precautions 8

Adverse events 9

Instructions for use 9

Sterilization 9
Preliminary procedures 9
Emptying the IsoMed pump 10
Refilling the IsoMed pump 13

Reservoir rinse procedure 16

Performing a reservoir rinse 16

Calculations for IsoMed pumps (fixed rate) only 16

Scheduling a refill 16
Calculating the time required for the drug to advance to the catheter
tip 17
Calculating flow rate 18
Calculating infusion solution 18
Calculating IsoMed pump flow rate accuracy 19

Technical support 20

Emergency procedures 21

Morphine intrathecal/epidural overdose 21
Emergency procedure to empty pump reservoir 23

Special notice 24

Limited Warranty 25

Medtronic® Neuromodulation MODEL 8553 REFILL KIT LIMITED
WARRANTY 25

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 refilling the pump reservoir.
Refer to the appropriate pump technical manual for implanting instructions.

Package contents

The Model 8553 Refill Kit contains the following sterile components that are
not made with natural rubber latex:

10-mL filling syringe

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60-mL lidded emptying syringe

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Fenestrated drape

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0.22-micron filter

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22-gauge noncoring needles (2)

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Template

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Extension set with a y-connector and a clamp

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Indications

The Model 8553 Refill Kit is intended for use in refilling Medtronic IsoMed
pumps.

Contraindications

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

Warnings

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.

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.

Refer to "Performing a reservoir rinse" on page 16 of this manual.
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 (pumps with catheter access ports) - Do not inject any
contrast medium into the pump reservoir. Injecting contrast medium into the
pump reservoir can impair pump operation.

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.

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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 anytime

▪

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

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

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

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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.

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.

Infusion solution calculations - Correct calculation of the infusion solution is
of critical importance in preventing overinfusion or underinfusion.

Refer to "Calculating infusion solution" on page 18 for instructions.
Injection error during a pump refill procedure - Be certain you are

accessing the correct port when injecting fluids into the reservoir fill port of an
implanted pump. ALWAYS:

identify the pump model and reservoir volume.

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identify the location of the reservoir fill port.

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use the instructions, noncoring needles, appropriate template, and

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

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

refer to the appropriate drug labeling for indications, contraindications,

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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
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 catheter access port may result in a
clinically significant or fatal drug overdose. Observe the patient after the

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pump refill procedure for any signs or symptoms that could indicate a
drug-related adverse event due to the pump refill procedure.

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.

Mixing drugs - The effects that drug mixtures have on pump operation are
unknown. Drugs can precipitate when mixed. These precipitates can inhibit
pump flow or block the catheter, resulting in loss of therapy or a clinically
significant or fatal drug underdose.

Overpressurization (IsoMed Pumps) - Do not overfill the pump reservoir.
Overfilling the pump reservoir can result in overpressurization and
overinfusion. Overinfusion can lead to a clinically significant or fatal drug
overdose. Overpressurization can damage the pump. To prevent overfilling:

Always identify the pump model and reservoir volume before filling or

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refilling;
Always empty the pump reservoir completely before filling or refilling;

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and
Do not exceed the maximum reservoir volume indicated in the pump

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labeling.

Patient travel - Patients should notify their clinicians of any travel plans.
Clinicians need this information to coordinate patient care and pump refills
and help prevent 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.

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.

Pump reservoir pressure (IsoMed Pumps) - Do not use an open syringe
when emptying the pump. The pump reservoir contents are under significant
pressure and can eject through an open syringe when emptying the pump.
Ejection of pump contents under pressure can result in procedural delays and
a potential risk to the clinician or patient.

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 - The appropriate Medtronic refill kit MUST be used
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.

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.

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

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