BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HOMEPUMP

    MDR report key: 7154517 · Received December 28, 2017

    Report

    Report Number
    MW5074301
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    December 15, 2017
    Report Date
    December 27, 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 # E252500, LOT # 0202736348) CONTAINING AZITHROMYCIN 500 MG IN 0.9 PERCENT. SODIUM CHLORIDE 250 ML WAS LEAKING FROM THE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929990 ECLIPSE HOMEPUMP ECLIPSE HOMEPUMP MEB HALYARD E252500 0202736348

    Patients

    Seq Age Sex Outcome Treatment
    1