BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL PLT, PLS, RBC SET

    MDR report key: 2232760 · Received July 19, 2011

    Report

    Report Number
    1722028-2011-00246
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 22, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK110009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE RUN DATA FILE (RDF) WERE ANALYZED. SIGNALS IN THE RUN DATA FILE INDICATE THAT THE ELEVATED WBC CONTENT IN THE PLATELET PRODUCT WAS LIKELY A RESULT OF A CONTINUOUS ESCAPE OF WBCS FROM THE LRS CHAMBER MIDWAY THROUGH THE PROCEDURE. THERE ARE NO EVENTS (ADJUSTMENTS, CHANGES IN PUMP SPEED, SUBSTRATE CHANGES, ETC.) IN THE PROCEDURE THAT CORRESPOND WITH THE ONSET OF THE OVERLOADING OF THE LRS CHAMBER. BASED ON THE AVAILABLE INFO, IT IS POSSIBLE THAT THIS LEUKOREDUCTION FAILURE COULD BE DONOR RELATED. INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    UNIT #(B)(4). THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR HIGHER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT. THE PT FELT LIGHT HEADED, BUT NO MEDICAL INTERVENTION WAS NECESSARY. THE DISPOSABLE KIT WAS DISCARDED THE SAME DAY OF THE PROCEDURE AND IS NOT AVAILABLE FOR RETURN. THE DONOR'S AGE IS UNAVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO A 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 06T3203

    Patients

    Seq Age Sex Outcome Treatment
    1