BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL PLT, PLS, RBC SET

    MDR report key: 2222516 · Received July 12, 2011

    Report

    Report Number
    1722028-2011-00111
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 16, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION: 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 THE 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. INCORRECT LOADING OF THE DISPOSABLE SET MAY CONTRIBUTE TO THIS SITUATION. INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED THAT THE RUN DATA FILE BE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WBC CONTENT IN THE PLATELET PRODUCT. THE DISPOSABLE SET WAS DISCARDED, THEREFORE, IS UNAVAILABLE TO BE RETURNED FOR INVESTIGATION. NO MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. DONOR UNIT# (B)(4). 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 04T2114

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other