Medtronic 8555 Instructions for Use
Refill Kit 8555
for use with Medtronic Implantable Infusion Pumps
Instructions for Use
Rx only
2000
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
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Medtronic, IsoMed, SynchroMed, and Medtronic logo are trademarks of
Medtronic.
®
MiniMed
is a registered trademark of Medtronic MiniMed, Inc.
4 English 2017-06-01
Table of contents
Introduction 7
Package contents 7
Indications 7
Contraindications 7
Warnings 7
Precautions 10
Adverse events 11
Instructions for use 12
For SynchroMed pump 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
For IsoMed pump 19
Sterilization 19
Preliminary procedures 19
Emptying the IsoMed pump 20
Refilling the IsoMed pump 23
Reservoir rinse procedure 26
Performing a reservoir rinse 26
Calculations for IsoMed pumps (fixed rate) only 26
Scheduling a refill 26
Calculating the time required for the drug to advance to the catheter
tip 27
Calculating flow rate 28
Calculating infusion solution 28
Calculating IsoMed pump flow rate accuracy 29
Technical support 30
Emergency procedures 31
Baclofen injection overdose 31
Baclofen injection underdose/withdrawal 33
Morphine intrathecal/epidural overdose 35
Emergency procedure to empty pump reservoir 37
Special notice 38
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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Limited Warranty 39
Medtronic® Neuromodulation MODEL 8555 REFILL KIT LIMITED
WARRANTY (U.S. Customers Only) 39
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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 8555 Refill Kit contains eight (8) sterile packs and each pack
contains the following sterile components that are not made with natural
rubber latex:
0.22-micron filter
▪
22-gauge noncoring needles (2)
▪
Template
▪
Extension set with a y-connector and a clamp
▪
Indications
The Model 8555 Refill Kit is intended for use in refilling Medtronic implantable
infusion pumps with the exception of Medtronic MiniMed infusion 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. For programmable infusion
pumps, 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 prior flow rate.
Refer to "Performing a reservoir rinse" on page 26 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.
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.
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
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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.
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 28 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.
▪
identify the location of the reservoir fill 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. 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
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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
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.
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
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).
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
▪
refilling;
Always empty the pump reservoir completely before filling or refilling;
▪
and
Do not exceed the maximum reservoir volume indicated in the pump
▪
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
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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
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.
Compatibility, all components - Follow these guidelines when selecting
system components:
Medtronic components: For proper therapy, use only components
▪
that are compatible with the appropriate indication.
Non-Medtronic components: No claims of safety, efficacy, or
▪
compatibility are made with regard to the use of non-Medtronic
components with Medtronic components. Refer to the non-Medtronic
documentation for information.
Component packaging - Before shipment the components in the sterile
package were sterilized by the process indicated on the package label. Do not
use or implant a component if the following circumstances have occurred:
The storage package or sterile seal has been pierced or altered
▪
because component sterility cannot be guaranteed and infection may
occur.
The component shows signs of damage because the component may
▪
not function properly.
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The use-by date has expired because component sterility cannot be
▪
guaranteed and infection may occur; also, device battery longevity
may be reduced and may require early replacement.
Infection - Use extreme caution when accessing the reservoir fill port or
catheter access port of the implanted pump if local or systemic infection is
suspected. Avoid contaminating the system or further spreading the infection.
Local or systemic infection may require pump revision or removal.
Reservoir valve activation (programmable pumps) - Do not prematurely
activate the pump reservoir valve. Activation of the pump reservoir valve
seals the pump reservoir valve closed. Unusual resistance or the inability to
inject the entire fill volume may indicate activation of the pump reservoir
valve. If the valve closes, a portion of the reservoir contents must be
delivered or removed before filling can be completed, and procedural delays
can occur. To prevent activation of the pump reservoir valve during emptying
and filling procedures:
completely aspirate all contents of the pump reservoir before filling;
▪
do not allow air into the pump reservoir through an open needle in the
▪
septum or an unclamped extension; and
do not exceed the maximum reservoir volume indicated in the pump
▪
labeling.
Single use only - Do not reuse any component. Components are intended
for single use only. Reusing components can result in inadequate therapy
and an increased risk of infection.
Storage temperature: kits and accessories - Do not store or transport the
kit device components or accessories above 57 °C (135 °F) or
below –34 °C (–30 °F). Temperatures outside this range can damage device
components.
Therapy discontinuance - If therapy is discontinued for an extended period,
fill the pump reservoir with preservative-free saline in intraspinal applications
or with the appropriate heparinized solution (if not contraindicated) in vascular
applications. For programmable pumps, program the pump to infuse at the
minimum flow rate. Refill the pump as needed to ensure the pump always
contains fluid in the reservoir and fluid pathway. Stopping the pump for
extended periods or allowing the pump reservoir to empty completely can
damage the system and require surgical replacement.
Vesicant drug (vascular applications) - Do not spill or leak vesicant or
cytotoxic drug into adjacent tissue during pump procedures. Spillage or
leakage of vesicant drug into adjacent tissue can result in significant local
tissue damage.
Vesicant/cytotoxic drugs at implant - Do not spill or leak vesicant or
cytotoxic drug into adjacent tissue during pump procedures. Spillage or
leakage of vesicant drug into adjacent tissue can result in significant local
tissue damage. If the drug to be used is a vesicant or has the potential to
cause local tissue damage, do not put the drug into the pump until after
implantation. Fill the pump and catheter with saline (a heparinized solution
may be used if not contraindicated) instead of the drug.
Adverse events
The adverse events associated with the use of this device may include, but
may not be limited to, the following:
Meningitis (intraspinal applications)
▪
Infection
▪
Reservoir contamination
▪
Overpressurization of the reservoir
▪
Injection into pocket or subcutaneous tissue
▪
Activation of reservoir valve
▪
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Instructions for use
Become thoroughly familiar with all product literature before using this refill kit.
Refer to the appropriate section based on the pump.
SynchroMed pump - go to page 12.
▪
IsoMed pump - go to page 19.
▪
For SynchroMed pump
Sterilization
All components of the kit are sterile. Do not resterilize. Should sterility of the
kit be in question, discard and use a new kit.
Preliminary procedures
1. Gather the following sterile equipment:
From the refill kit:
Extension set with a y-connector and a clamp
▪
0.22-micron filter
▪
22-gauge noncoring needle
▪
Template
▪
Locally supplied:
10-mL filling syringe, optional
▪
20-mL empty syringe(s)
▪
Fenestrated drape
▪
Syringe containing prescribed fluid
▪
Cleansing agent
▪
Sterile gloves
▪
Alcohol pads or swabs
▪
Adhesive bandage, optional
▪
2. Refer to the appropriate drug labeling for indications, contraindications,
warnings, precautions, dosage and administration information, and
screening procedures.
3. Prepare the programmer for use. Refer to the appropriate programming
guide for instructions.
4. Confirm the:
pump model
▪
reservoir volume (ie, expected volume)
▪
location of the pump
▪
Note: The model and reservoir volume can be confirmed by the
programmer. Alternatively, a radiopaque identifier in the pump shows
the pump model and identifies Medtronic as the pump manufacturer on
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a standard x-ray (Figure 1). A three-letter code designates the pump
model.
Radiopaque identifier
Medtronic symbol
Model designator
Figure 1. A radiopaque identifier on a SynchroMed II pump.
5.
Confirm that the volume of the prescribed fluid does not exceed the
reservoir volume of the pump.
Emptying the SynchroMed pump
1. Prepare the injection site by cleansing the area.
2. Open the kit. Put on sterile gloves.
3. Place the drape, exposing the pump site.
4. Using sterile procedures, assemble the needle, extension set, and
empty syringe as follows:
a. Connect the empty syringe to the extension set (Figure 4).
b. Connect the needle to the extension set.
5. Palpate the pump and identify the location of the catheter access port
and the edges of pump.
Factors that may make it difficult to locate the pump include, but are not
limited to:
deep implant
▪
patient position (eg, a seated patient)
▪
scar tissue at the pump implant site
▪
seroma
▪
the pump is tilted in the pocket
▪
obesity
▪
pump movement within the pocket
▪
weight gain after implant
▪
weight loss after implant
▪
If you have difficulty identifying the pump features, you may seek
assistance from another clinician. If deemed necessary by the clinician,
x-ray and fluoroscopy can be used to assist in locating or determining
the orientation of the pump.
6. Place the template on the skin over the pump, and align the refill
template correctly based on the model of the pump that is being refilled
(Figure 2). Align the edges of the template with the edges of the pump.
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