FDA Adverse Event Other Summary report: N

VERIFUSE INFUSION PUMP

MDR report key: 14348 · Received June 27, 1994

Report

Report Number
MW1002603
Event Type
Other
Date Received
June 27, 1994
Date of Event
May 26, 1994
Report Date
May 31, 1994
Manufacturer
BLOCK MEDICAL, INC.
Product Code
MEA
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

PT SENT HOME ON MORPHINE SULFATE SC 8 MG/HR CONTINUOUS WITH 8 MG BOLUS EVERY 10 MINUTES MAXIMUM 6 BOLUSES PER HR AS NEEDED. PT WAS SENT HOME AT 3 PM. PT ARRIVED HOME AT 6 PM, WITH AIR-IN-LINE DETECTOR ALARMING. BOLUS WAS GIVEN, REMOVING AIR AND STOPPING ALARM. AT 9 PM, THE AIR-IN-LINE DETECTOR WAS ARLARMING. THE NURSE DEACTIVATED THE AIR-IN-LINE DETECTOR. THE OCCLUSION ALARM WENT OFF WHEN THE BOLUS DOSE WAS GIVEN, ONCE ON 5/26/94, AND TWICE ON 5/27/94. THE PT REQUIRED INSERTION OF A PERIPHERAL LINE. ON 5/31/94, AFTER INSERTION OF PERIPHERAL LINE AND DEACTIVATION OF THE AIR-IN-LINE DETECTOR, THE PT WAS EXPERIENCING NO PROBLEMS. RPTR FEELS THE AIR-IN-LINE DETECTOR IS TOO SENSITIVE, CAUSING DEACTIVATION, THE PUMP IS NOT RECOMMENDED FOR SC DOSING. THE TUBING WAS PROPERLY PLACED ON THE PUMP AIR-IN-LINE DETECTOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VERIFUSE INFUSION PUMP INFUSION PUMP MEA BLOCK MEDICAL, INC. V001500, VERISON 4.11

Patients

Seq Age Sex Outcome Treatment
1 * Other