BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL PLT, PLS, RBC SET

    MDR report key: 2192559 · Received July 1, 2011

    Report

    Report Number
    1722028-2011-00185
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 6, 2011
    Manufacturer
    CARDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER WAS UNSURE OF THE LOT NUMBER. IT MAY HAVE BEEN LOT NUMBER 05T3104, EXP DATE 05/01/2013. INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYSED FOR THIS EVENT. SIGNALS IN THE RDF DID NOT INDICATE A CONCLUSIVE CAUSE FOR THE GREATER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT REPORTED FOR THIS COLLECTION. NO UNUSUAL PROCESS VARIABLE WAS IDENTIFIED IN THE RDF AND THE TRAUMA ACCEL SYSTEM OPERATED AS INTENDED. BASED ON THE AVAILABLE INFO, IT IS POSSIBLE THAT A SAMPLING, CALCULATION, OR OTHER PROCESS ERROR MAY HAVE CONTRIBUTED TO THE HIGHER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT. INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN PROCESS. A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE HIGHER THAN EXPECTED RWBC CONTENT IN THE PLATELET PRODUCT. NO MEDICAL INTERVENTION WAS REQUIRED. THE COMPLAINT WAS IDENTIFIED BY THE CUSTOMER'S LAB AFTER THE DISPOSAL HAD ALREADY BEEN DISCARDED, THEREFORE, IT IS UNAVAILABLE FOR RETURN FOR EVAL. (B)(6). THIS REPORT IS BEING FILED DUE TO 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 CARDIANBCT 05T2118

    Patients

    Seq Age Sex Outcome Treatment
    1