BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HOMEPUMP

    MDR report key: 7376836 · Received March 27, 2018

    Report

    Report Number
    MW5076177
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    March 26, 2018
    Report Date
    March 26, 2018
    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 # 0202822051) CONTAINING AZITHROMYCIN 500 MG IN 0.9 PERCENT SODIUM CHLORIDE 250 MLS, TUBING CAME APART AT THE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215843 ECLIPSE HOMEPUMP PUMP, INFUSION, ELASTOMERIC MEB HALYARD E252500 0202822051

    Patients

    Seq Age Sex Outcome Treatment
    1