BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HOMEPUMP

    MDR report key: 6311700 · Received February 6, 2017

    Report

    Report Number
    MW5067749
    Event Type
    Malfunction
    Date Received
    February 6, 2017
    Date of Event
    February 2, 2017
    Report Date
    February 6, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AFTER FILLING THE ECLIPSE HOME PUMP (MODULE #E252500, LOT #0202510784 WITH PRIMAXIN 1 GRAM IN 0.9% SODIUM CHLORIDE 250ML, IT WAS NOTICED THAT THERE WAS LEAKING FROM THE TOP OF THE ELASTOMERIC TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89114 ECLIPSE HOMEPUMP ECLIPSE HOMEPUMP MEB HALYARD HEALTH E252500 0202510784

    Patients

    Seq Age Sex Outcome Treatment
    1 PRIMAXIN 1 GRAM IN 0.9% SODIUM CHLORIDE 250ML.