BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HOME PUMP

    MDR report key: 32249 · Received April 25, 1996

    Report

    Report Number
    MW1008955
    Event Type
    Malfunction
    Date Received
    April 25, 1996
    Date of Event
    April 24, 1996
    Report Date
    April 24, 1996
    Manufacturer
    BLOCK MEDICAL, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT REMOVED THE PCN 6 MU IN A 100 ML/HR PUMP FROM THE REFRIGERATOR RIGHT BEFORE INFUSION. SINCE THE MEDICATION WAS COLD, PT CALLED THE RN FOR DIRECTIONS TO WARM UP THE PCN. AS PER RN DIRECTIONS, THE PT PLACED THE PCN PUMP INTO THE MICROWAVE WHICH RESULTED IN EXPLOSION OF THE PUMP. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE HOME PUMP ELASTOMERIC PUMP MEB BLOCK MEDICAL, INC. 101000-B 55039

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR