BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLT, PLS, RBC SET

    MDR report key: 2222361 · Received August 19, 2011

    Report

    Report Number
    1722028-2011-00292
    Event Type
    Other
    Date Received
    August 19, 2011
    Date of Event
    July 24, 2011
    Report Date
    July 25, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK110009
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 12X10^6 FOR APHERESIS PLATELET PRODUCT TRIPLE 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 WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT THAT WAS FOUND BY THEIR LAB AFTER A TRIPLE PLATELET PRODUCT COLLECTION. DONOR UNIT # (B)(4). NO MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. THE DISPOSABLE SET IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO AN ALLEGED 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 07T2105

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR