BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFUSE PUMP

    MDR report key: 18811 · Received January 6, 1995

    Report

    Report Number
    MW1004673
    Event Type
    Injury
    Date Received
    January 6, 1995
    Date of Event
    December 13, 1994
    Report Date
    December 15, 1994
    Manufacturer
    BLOCK MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT ON MORPHINE INFUSION SUDDENLY BECAME OVERLY SEDATED, REQUIRING NALOXONE TO REVERSE. NURSE ATTEMPTED TO "TEST" PUMP AND CLAIMS PUMP WAS DELIVERING AT A RATE FASTER THAN THE PROGRAMMED 0.4 ML/HR. WHEN RETURNED TO RPTR, HE ATTEMPTED TO MEASURE OUTPUT BUT PUMP REGISTERED "MALFUNCTION" COMMAND BEFORE PUMPING BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFUSE PUMP IV PUMP FRN BLOCK MEDICAL, INC. V001500-801

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention