PROMETRA® II PROGRAMMABLE PUMP
Page 7 of 38
Warnings
General
WARNING: USE OF UNAPPROVED DRUGS (e.g., DRUG COCKTAILS, PHARMACY-COMPOUNDED
DRUGS, MORPHINE WITH PRESERVATIVES, ETC.) WITH THE PROMETRA II PUMP COULD RESULT
IN PUMP FAILURE AND/OR SERIOUS ADVERSE EVENTS INCLUDING DEATH.
WARNING: FAILURE TO EMPTY THE PUMP PRIOR TO EXPOSURE TO MRI ENVIRONMENT COULD
RESULT IN DRUG OVERDOSE THAT COULD LEAD TO SERIOUS PATIENT INJURY OR DEATH.
•
Prior to infusion of Infumorph into the catheter, medical personnel should be familiar with and
observe all warnings, cautions, contraindications, and instructions as specified by the drug
manufacturer.
•
Patients should not undergo hyperbaric therapy since exposure could result in drug underdose.
•
Always select and program dosages consistent with the Infumorph® labeling to prevent improper
drug administration.
•
In the event of over-medication, refer to the approved Infumorph labeling for appropriate
treatment.
•
Clinicians implanting, programming, accessing, or maintaining implanted programmable pumps
must comply with the instructions for use. Technical errors may result in a return of underlying
symptoms, drug withdrawal symptoms, or clinically significant or fatal overdose.
•
The Prometra II Programmable Pump components are supplied sterile and non-pyrogenic. The
packages should be examined carefully prior to opening. Do not use the contents if there is any
evidence of damage to the package or package seal that could compromise sterility. Do not
resterilize contents of any damaged or opened packages.
•
After use, this device is a biohazard. Handle and dispose of in accordance with accepted hospital
practice and all applicable laws and regulations.
•
Do not incinerate or cremate the pump.
•
Do not expose the pump to temperatures above 57˚C (134.6˚F) or below 2˚C (35.6˚F).
•
The patient has an occupation where he/she would be exposed to high current industrial
equipment, powerful magnets or transmitting towers, such as, electricians, electrical engineers or
MRI technicians.
