BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTA MIX, BAXTER INTERNATIONAL INC. EXACTAMIX, 2000ML CONTAINER

    MDR report key: 5942446 · Received September 6, 2016

    Report

    Report Number
    MW5064649
    Event Type
    Injury
    Date Received
    September 6, 2016
    Date of Event
    September 5, 2016
    Report Date
    September 6, 2016
    Manufacturer
    EXACTA MIX, BAXTER INTERNATIONAL INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EXACTAMIX 2000ML EVA CONTAINER HAS 3 PORTS AT BOTTOM OF BAG. THE MIDDLE PORT COMPLETELY COMES OFF WHEN NURSE TRIES TO HANG ON PT. PHARMACY CONTACTED DRUG REP AND NOTHING HAS BEEN DONE TO FIX THIS. THIS HAS HAPPENED SEVERAL TIMES AND ALL COME FROM THE SAME LOT NUMBER OF 1135577, EXP 2019-03 9083 04.04.16 18:05. 06, REF (B)(4) MANUFACTURED BY BAXTER AND EXACTA MIX, BAXTER INTERNATIONAL INC. THIS IS COSTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582867 EXACTA MIX, BAXTER INTERNATIONAL INC. EXACTAMIX, 2000ML CONTAINER 2000ML BAG LHI EXACTA MIX, BAXTER INTERNATIONAL INC. 1135577

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXACTAMIX 2000ML EVA CONTAINER USED MULTIPLE TIMES| ON DIFFERENT PATIENTS.