BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX EVA BAG

    MDR report key: 4800429 · Received May 27, 2015

    Report

    Report Number
    1419106-2015-00103
    Event Type
    Malfunction
    Date Received
    May 27, 2015
    Date of Event
    January 21, 2015
    Report Date
    April 27, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KPE
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLES WERE RETURNED FOR EVALUATION. AS THE LOT NUMBER WAS NOT PROVIDED, A BATCH REVIEW WAS NOT POSSIBLE. THE REPORTING FACILITY INFORMED BAXTER THAT A LABORATORY ANALYSIS IDENTIFIED THE PARTICULATE MATTER AS MULTI POLYACRYLIC CRYOLITE; HOWEVER, NO TESTING DATA WAS PROVIDED TO BAXTER. ALTHOUGH THE CAUSE OF THE REPORTED EVENT IS UNKNOWN, MULTI POLYACRYLIC CRYOLITE IS NOT USED IN ANY OF THE COMPONENTS OF THIS DEVICE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TPN THERAPY BAG WAS FOUND TO HAVE PARTICULATE WITHIN THE BAG. THE PARTICULATE WAS DISCOVERED DURING THE PHARMACY QUALITY CONTROL CHECK; THEREFORE, NO PATIENT INVOLVEMENT OR ADVERSE EVENTS OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342667 EXACTAMIX EVA BAG EVA TPN BAG KPE BAXTER HEALTHCARE CORPORATION 740 NI

    Patients

    Seq Age Sex Outcome Treatment
    1