BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HOMEPUMP

    MDR report key: 7013447 · Received November 9, 2017

    Report

    Report Number
    MW5073188
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    November 6, 2017
    Report Date
    November 7, 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

    UPON DELIVERY, IT WAS NOTICED THAT ONE (1) ELASTOMERIC DEVICE, FILLED WITH MEROPENEM 1 GRAM/0.9% SODIUM CHLORIDE 250 ML, MODEL # E252500, LOT #0202730910 LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795873 ECLIPSE HOMEPUMP PUMP INFUSION, ELASTOMERIC MEB HALYARD E252500 0202730910

    Patients

    Seq Age Sex Outcome Treatment
    1