BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLT, PLS, RBC SET

    MDR report key: 2181546 · Received July 18, 2011

    Report

    Report Number
    1722028-2011-00236
    Event Type
    Other
    Date Received
    July 18, 2011
    Date of Event
    May 2, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE RUN DATA FILES (RDF) WERE ANALYZED. SIGNALS IN THE RUN DATA FILE DO NOT INDICATE A CONCLUSIVE CAUSE FOR THE GREATER THAN EXPECTED WBC COUNT IN THE PLATELET PRODUCT. THE RDF INDICATES THAT THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. THE MEASURED WBC COUNT IS WITHIN THE LEUKOREDUCTION ACCEPTANCE CRITERIA OR 12 X 10 TO THE POWER OF 6 FOR TPP COLLECTIONS. CONCLUSION: NO DEVICE FAILURE. COLLECTED PRODUCT IS WITHIN SPECS.

    Description of Event or Problem · 1

    THE CUSTOMER PERFORMED A TRIPLE PLATELET PRODUCT (TPP) COLLECTION AND WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WBC CONTENT IN THE PLATELET PRODUCT. NO MEDICAL INTERVENTION WAS NECESSARY REGARDING THIS INCIDENT. THE DISPOSABLE KIT WAS DISCARDED THE SAME DAY AND IS NOT AVAILABLE FOR RETURN. UNIT # (B)(4). THIS REPORT IS BEING FILED DUE TO AN ALLEGED DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLT, PLS, RBC SET AUTOMATED BLOOD CELL SEPARATOR LKN CARIDIANBCT 04T3211

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other