BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL PLT, PLS, RBC SET

    MDR report key: 2232762 · Received July 19, 2011

    Report

    Report Number
    1722028-2011-00113
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    January 21, 2011
    Report Date
    June 23, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE RUN DATA FILES (RDF) WERE ANALYZED. SIGNALS IN THE RUN DATA FILE INDICATE THAT THE PLASMA LINE MAY HAVE BEEN PARTIALLY OCCLUDED NEAR THE END OF THE PROCEDURE. IF THE PLASMA LINE DOES NOT CONTRIBUTE PROPERLY TO THE PLATELET PUMP, IT COULD CAUSE FLOW THROUGH THE LRS CHAMBER TO BE HIGHER THAN THE SYSTEM EXPECTS, THEREFORE ALLOWING SOME WBCS TO ESCAPE AND END UP IN THE PRODUCT BAG. ORIENTATION OF THE HEX IN THE HEX HOLDER MAY CONTRIBUTE TO THIS SITUATION. INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    DONOR UNIT #: (B)(6). THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WBC CONTENT IN THE PLATELET PRODUCT. NO MEDICAL INTERVENTION WAS NECESSARY FOR THIS INCIDENT. THE DISPOSABLE KIT WAS NOT AVAILABLE FOR EVAL BECAUSE, IT WAS DISCARDED THE SAME DAY AS THE PROCEDURE. THIS REPORT IS BEING FILED DUE TO DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLT, PLS, RBC SET AUTOMATED BLOOD CELL SEPARATOR LKN CARIDIANBCT 12S3216

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other