BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HOMEPUMP

    MDR report key: 6861536 · Received September 12, 2017

    Report

    Report Number
    MW5072120
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    September 7, 2017
    Report Date
    September 11, 2017
    Manufacturer
    HALYARD
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ECLIPSE HOMEPUMP (MODEL # E101000, LOT # 0202645051) CONTAINED PIP/TAZO 3.375 GRAMS/75 ML OF 0.9 SODIUM CHLORIDE LEAKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637697 ECLIPSE HOMEPUMP ECLIPSE HOMEPUMP MEB HALYARD E101000 0202645051

    Patients

    Seq Age Sex Outcome Treatment
    1