BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HOMEPUMP

    MDR report key: 5725463 · Received June 13, 2016

    Report

    Report Number
    MW5062844
    Event Type
    Malfunction
    Date Received
    June 13, 2016
    Date of Event
    April 27, 2016
    Report Date
    June 10, 2016
    Manufacturer
    KIMBERLY-CLARK
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TUBING DETACHED FROM ECLIPSE HOMEPUMP, MODEL #E101000 THAT WAS FILLED WITH VANCOMYCIN 500 MG/NS 100 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374936 ECLIPSE HOMEPUMP ECLIPSE HOMEPUMP FPA KIMBERLY-CLARK E101000

    Patients

    Seq Age Sex Outcome Treatment
    1