BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP ECLIPSE

    MDR report key: 76157 · Received March 14, 1997

    Report

    Report Number
    MW1010954
    Event Type
    Malfunction
    Date Received
    March 14, 1997
    Date of Event
    March 12, 1997
    Report Date
    March 12, 1997
    Manufacturer
    BLOCK MEDICAL, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WHILE COMPOUNDING ELASTOMERIC PUMP TWO PRODUCTS WERE DISCOVERED WITH A SMALL OBJECT (LOOKS PLASTIC) 1/6 INCH LONG BY 1/32 WIDE FLOATING IN THE SOLUTION AFTER FILLING WITH 0.9 NORMAL SALINE. ANOTHER PUMP WAS DISCOVERED LAST WEEK WITH WHAT APPEARS TO BE A HAIR BETWEEN THE INNER AND OUTER SHELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEPUMP ECLIPSE ELASTOMERIC INFUSION PUMP MEB BLOCK MEDICAL, INC. E10200-C 712014

    Patients

    Seq Age Sex Outcome Treatment
    1 *