BEUDAMED
    FDA Adverse Event Summary report: N

    EXACTAMIX EVA BAG

    MDR report key: 4962249 · Received August 3, 2015

    Report

    Report Number
    1419106-2015-00154
    Date Received
    August 3, 2015
    Report Date
    August 4, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KPE
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE: UNKNOWN. NO SAMPLES WERE RETURNED FOR EVALUATION. A BATCH REVIEW WAS NOT POSSIBLE IN THIS INSTANCE, AS THE LOT NUMBER WAS NOT PROVIDED. ALTHOUGH NO SAMPLE HAS BEEN RETURNED FOR EVALUATION, THE INITIAL REPORTER DID INFORM BAXTER THAT THE NURSE SPIKED THE WRONG PORT ON THE TPN BAG; THEREFORE, THE EVENT WAS DETERMINED TO BE RELATED TO USER ERROR. THE INSTRUCTIONS FOR USE FOR THIS DEVICE CONTAIN A DIAGRAM OF THE BAG AND ITS PORTS, AND GIVES DIRECTION FOR THE USER TO SPIKE THE ADMINISTRATION PORT FOR SOLUTION ADMINISTRATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO INFUSE THE MEDICATION DOBUTAMINE FOR A HOME CARE PATIENT, A NURSE SPIKED THE CLAMPED FILL PORT OF THE TPN BAG, RATHER THAN THE ADMINISTRATION PORT. THE NURSE THEN BEGAN INFUSION, ASSUMING THE MEDICATION WAS BEING DELIVERED. THE ERROR WAS DISCOVERED THE FOLLOWING DAY, WITH NO ADVERSE EVENTS REPORTED, ALTHOUGH, THE PATIENT DID NOT RECEIVE THE INTENDED THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505916 EXACTAMIX EVA BAG EVA TPN BAG KPE BAXTER HEALTHCARE CORPORATION 737 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR