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Adverse events related to filling or refilling the pump, such as:
•
Contamination of the reservoir, which can lead to infection or meningitis
•
Injection errors, which can lead to tissue damage or a drug under- or overdose
•
Overfilling of the reservoir, which can lead to drug overdose or damage to
the pump
•
Air in the pump reservoir may cause the infusion rate to exceed the
programmed rate, leading to drug overdose.
Other adverse events such as:
•
Foreign body rejection phenomena
•
Post-surgical pain or discomfort
•
Skin erosion or wound dehiscence of the pocket
Patient Information
Inform patients of the significance of the pump alarm and instruct them
to call the clinic or physician's office immediately if the alarm sounds.
Inform patients that elevated body temperature and changes in atmospheric
pressure can alter the flow rate of the pump. Fever can cause elevated body
temperature. Living in or traveling to high altitude areas, traveling in unpressurized
aircraft, taking long flights in pressurized aircraft, or SCUBA diving, can cause
changes in atmospheric pressure.
Inform patients of the following limitations:
•
Do not go SCUBA diving or deep sea diving
•
Do not use hyperbaric chambers
•
Do not use transcutaneous electrical nerve stimulation (TENS) in the area of
the pump
•
Avoid high-energy radio frequency equipment, such as radio transmitters and
security gates
•
Inform security personnel at airports, etc., that the implanted pump prevents
the safe use of security gate screening
Instruct patients as follows:
•
Immediately contact the physician's office if the alarm sounds
•
Do not manipulate the pump or handle it excessively through the skin.
This is known as Twiddler's Syndrome and can cause catheter disconnection
or kinking
•
Keep the implant site clean, dry, and protected from external pressure
or irritation
•
Avoid physical activities that might damage the implant site or the device
•
Carry their patient identification card at all times
•
Notify their personal and consulting physicians that they have an
implanted pump
•
Consult their physician if they notice any unusual signs or symptoms
10
•
Report any change in the effectiveness of therapy after exposure to
industrial environments, such as electrical substations, arc welding,
and other industrial equipment
•
Report any change in the effectiveness of therapy after exposure to high-energy
radio frequency equipment, such as transmitters and security gates
•
Return for refills at the prescribed time and notify their physicians about travel
plans so that pump refills can be scheduled
•
Inform the clinic or physician's office before travel to a distant time zone.
It might be necessary to change the dosage schedule to conform (for variable
dosage programs only)
Notify patients of the appropriate warnings and precautions associated with the
prescribed drug, including overdose and underdose signs and symptoms.
Inform patients of the importance of return visits to the clinic or physician's office
at regular intervals to monitor system performance.
Drug Stability Information
Only the drugs listed below can be used with the MedStream pump for the
indications previously described. Mix these drugs only with preservative-free
sterile solution of 0.9% sodium chloride to achieve the appropriate concentration.
Table 2
Drug Stability Information
Drug Name
Preservative-free morphine sulfate sterile
solution
Preservative-free baclofen sterile solution
Refer to the drug labeling for complete prescribing information, indications,
contraindications, warnings, precautions, and adverse events.
When filling the reservoir, verify that the "Use By" date of the drug will not occur
before the patient's next refill.
PRODUCT DESCRIPTION
Pump (see Figure 1)
The MedStream Programmable Infusion Pump is designed to deliver drug
therapy at precise flow rates. This is made possible by the use of flow-restrictor
chip combined with a miniaturized gating valve technology in the pump design.
The titanium pump utilizes a butane drive medium.
The pump is available in different reservoir sizes. Please contact your local
Codman representative for ordering information.
Stability Duration
120 days
120 days
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