BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HOMEPUMP

    MDR report key: 20142 · Received March 6, 1995

    Report

    Report Number
    MW1005336
    Event Type
    Malfunction
    Date Received
    March 6, 1995
    Report Date
    March 3, 1995
    Manufacturer
    BLOCK MEDICAL, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WHEN FILLING THE PUMPS ON OCCASION, THE CHECK VALVE AT THE FILL PORT DOES NOT FUNCTION PROPERLY AND ALL FLUIDS THAT ALREADY HAD BEEN INTRODUCED TO THE PUMP ARE RELEASED AT SIGNIFICANT FORCE. THIS ALL RESULTS IN THE LOSS OF MEDICATIONS, THE PUMP, CLEAN UP MATERIALS, TIME EXPOSURE TO MEDICATIONS AND POSSIBLE CONTAMINATION OF OTHER PRODUCT AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE HOMEPUMP MEB BLOCK MEDICAL, INC. E101000 45138, 45021

    Patients

    Seq Age Sex Outcome Treatment
    1 *