BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3000 ML TPN BAG

    MDR report key: 6109420 · Received November 17, 2016

    Report

    Report Number
    1416980-2016-17400
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 24, 2016
    Report Date
    December 20, 2016
    Manufacturer
    BAXTER HEALTHCARE - ENGLEWOOD
    Product Code
    LHI
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. A FUNCTIONAL LEAK TEST WAS PERFORMED AND TWO LARGE LEAKS WERE LOCATED ON THE BACKSIDE OF THE BAG NEAR THE LEFT EDGE. MICROSCOPIC EXAMINATION REVEALED THAT THERE WERE SMALL, HALF CIRCLE SHAPED PUNCTURES, POSSIBLY CREATED BY ACCIDENTAL PUNCTURE BY A CANNULA (CANNULA EVA PUNCTURES GENERALLY HAVE THIS SHAPE). THERE WAS NO PUNCTURE MARKING OR IMPRESSION ON THE OPPOSITE FACE OF THE EVA, WHICH INDICATES THAT THIS OCCURRED WHEN THE BAG WAS FULL. THE MANUAL ADD PORT HAD BEEN USED, EVIDENT BY A CANNULA INSERTION POINT. CAUSE OF THIS ISSUE WAS DUE TO DAMAGE AFTER FILLING. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EXACTAMIX EVA BAG WAS LEAKING FROM SEVERAL PIN HOLES IN THE BAG SEAM. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760828 3000 ML TPN BAG SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - ENGLEWOOD NA 1122056

    Patients

    Seq Age Sex Outcome Treatment
    1