BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX 2000ML EVA CONTAINERS - EMPTY

    MDR report key: 10477251 · Received August 31, 2020

    Report

    Report Number
    MW5096354
    Event Type
    Malfunction
    Date Received
    August 31, 2020
    Date of Event
    August 27, 2020
    Report Date
    August 28, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DURING OUR INPATIENT PHARMACY'S PREPARATION OF DAILY PARENTERAL NUTRITION SUPPLY - TWO 2-LITER BAGS OF SOLUTION THAT HAD JUST BEEN PUMPED WERE FOUND TO BE LEAKING FROM THE MIDDLE PORT OF THE BAGS. (THIS WAS NOTED TO BE OCCURRING FROM THE "CENTER" PORT, NORMALLY USED BY RNS WHEN ATTACHING INFUSION LINES TO THE BAG, WHICH STILL HAD THE CLEAR PLASTIC TABS ATTACHED, AND HAD NOT YET BEEN MANIPULATED DURING OUR PRODUCTION PROCESS.) PRODUCT INFORMATION: EXACTAMIX 2000ML EVA CONTAINERS, REF # H938740, (LOT # IS 60231190) BAXTER HEALTHCARE (B)(4) - AN AFFILIATE OF BAXTER HEALTHCARE CORP, USA - PRODUCT OF (B)(4). AN ADDITION (B)(4) BAGS OF THE SAME LOT WERE IDENTIFIED AND REMOVED FROM OUR STOCK SUPPLY FOR NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939112 EXACTAMIX 2000ML EVA CONTAINERS - EMPTY SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION 60231190
    939113 EXACTAMIX 2000ML EVA CONTAINERS - EMPTY SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION 60231190

    Patients

    Seq Age Sex Outcome Treatment
    1