BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCELL PLT, PLS, RBC SET

    MDR report key: 2240594 · Received August 26, 2011

    Report

    Report Number
    1722028-2011-00305
    Event Type
    Other
    Date Received
    August 26, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 1, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK110009
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE RUN DATA FILE WAS ANALYZED. SIGNALS INDICATE THAT THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. THE MEASURED WBC CONTENT IS WITHIN THE FDA'S CURRENT ACCEPTABLE LIMITS OF 8.0 X 10^6 FOR APHERESIS PLATELET PRODUCT DOUBLE COLLECTIONS. CONCLUSION: NO FAILURE OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WBC CONTENT THAT WAS MEASURED IN THE PLATELET PRODUCT AFTER A DOUBLE PLATELET PRODUCT PLATELET ONLY COLLECTION. DONOR UNIT# (B)(6). NO MEDICAL INTERVENTION WAS NECESSARY FOR THIS EVENT. THE CUSTOMER DISCARDED THE DISPOSABLE SET, THEREFORE, IT IS NOT AVAILABLE TO BE RETURNED FOR EVAL. THIS REPORT IS BEING FILED DUE TO AN ALLEGED DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCELL PLT, PLS, RBC SET AUTOMATED BLOOD CELL SEPARATOR LKN CARIDIANBCT 07T3105

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR