BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLT, PLS, RBC SET

    MDR report key: 2132476 · Received June 13, 2011

    Report

    Report Number
    1722028-2011-00173
    Event Type
    Other
    Date Received
    June 13, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 18, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROGRESS. A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE TECH FOUND THE SUPERNATANT PLASMA ALLEGEDLY HAD HEMOLYSIS IN THE SAMPLE TUBE. THE BLOOD SAMPLE WAS TAKEN FROM THE SAMPLE BAG AFTER BEING CONNECTED TO THE DONOR. IT WAS THEN TRANSFERRED TO THE VACUUM TUBE. THE BLOOD SAMPLE RESTED ABOUT 1 HOUR, THEN WAS SEPARATED BY CENTRIFUGE. THE TECH THEN ALLEGEDLY FOUND THAT THE SUPERNATANT PLASMA WAS PINK. CARIDIANBCT IS AWAITING THE RETURN OF THE DISPOSABLE. PT INFO IS UNAVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO POTENTIAL HEMOLYSIS FOUND IN A BLOOD SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLT, PLS, RBC SET SEPARATOR, AUBOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 02T3303

    Patients

    Seq Age Sex Outcome Treatment
    1 Other