PROMETRA® II PROGRAMMABLE PUMP
Page 13 of 38
IN THE EVENT OF A MEDICAL EMERGENCY REQUIRING AN MRI SCAN:
Prometra
®
Programmable Pump (REF 11827)
Medication
MUST
be removed from the Prometra
®
Pump REF 11827. Do not expose patient to MRI magnetic
fields with drug in the Prometra Drug Reservoir, even in the event of a medical emergency. Follow
instructions above (Pre-MRI) for removing drug from the Prometra Pump.
Prometra
®
II Programmable Pump (REF 13827)
In the event of a medical emergency requiring a STAT MRI, the treating physician must be aware of the
following as inputs to decision making regarding proceeding with an Emergency MRI for the Prometra II
Pump (REF 13827):
WARNING:
In the event an MRI scan was performed on a patient with a
Prometra
®
II Pump
where the drug was NOT removed due to a medical emergency situation, the
Prometra
®
II
Pump
contains a Flow Activated Valve (FAV) intended to reduce, but not eliminate, the risk of
drug overdose. A physician must evaluate the patient immediately for signs and symptoms of
drug overdose and develop a plan for immediate monitoring in a medically supervised and
adequately equipped environment. Resuscitative equipment should be available, as should
medications to manage drug overdose.
FLOWONIX STRONGLY RECOMMENDS THAT ALL DRUG BE REMOVED FROM THE PROMETRA
®
II DRUG
RESERVOIR PRIOR TO ANY MRI SCAN.
The Prometra
®
II Pump includes a Flow Activated Valve (FAV) intended to reduce, but not
eliminate, the risk of drug over-infusion during an MRI procedure.
If the Drug Reservoir volume is ≤1mL or expected to be ≤1mL at the time of the Emergency MRI scan, do
not proceed with an Emergency MRI scan without first emptying the drug from the Reservoir, If there is
≤1mL of drug in
the Reservoir, the drug must be removed prior to the Emergency MRI procedure. When
the Reservoir volume is at < 1 mL, the FAV may not close.
Thus, the drug within the Reservoir may be
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.
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.
