BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL ENHANCED PLT, PLS, RBC SET

    MDR report key: 2210109 · Received August 5, 2011

    Report

    Report Number
    1722028-2011-00262
    Event Type
    Other
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 11, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RUN DATA FILE WAS REVIEWED. SIGNALS INDICATE THAT THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. THE MEASURED WBC COUNT OF THE PRODUCT DOES NOT QUALIFY AS A WBC FAILURE PER THE CURRENT FDA GUIDELINES OF 8 X 10^6 FOR A DOUBLE PLATELET PRODUCT COLLECTION. 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 COLLECTION. DONOR UNIT #: (B)(4). NO MEDICAL INTERVENTION WAS REQUIRED. THE DISPOSABLE SET IS NOT BEING RETURNED FOR EVAL. THIS REPORT IS BEING FILED DUE TO ALLEGED DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL ENHANCED PLT, PLS, RBC SET AUTOMATED BLOOD CELL SEPARATOR LKN CARIDIANBCT 05T1217

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR