BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP DISPOSABLE ELASTOMERIC DEVICE

    MDR report key: 27779 · Received November 2, 1995

    Report

    Report Number
    MW1007551
    Event Type
    Malfunction
    Date Received
    November 2, 1995
    Date of Event
    October 24, 1995
    Report Date
    October 25, 1995
    Manufacturer
    BLOCK MEDICAL, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PUMP WAS FILLED WITH 450 ML OF DRUG AND DILUENT. PUMP SHOULD HAVE RUN OVER 4.5 HRS. PUMP RATE WAS 100 ML/HR. IT INFUSED OVER 2 HRS. PUMP WAS RETRIEVED BY NURSE. RPTR FILLED IT UP WITH 450 ML OF FLUID AGAIN AND IT RAN OVER 2 HRS AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEPUMP DISPOSABLE ELASTOMERIC DEVICE ELASTOMERIC PUMP MEB BLOCK MEDICAL, INC. H251000 43920

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other