BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL PLT, PLS, RBC SET

    MDR report key: 2192558 · Received July 1, 2011

    Report

    Report Number
    1722028-2011-00200
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    CARIDIAN BCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RUN DATA FILE WAS REVIEWED AND BASED ON THE AVAILABLE INFO, IT IS POSSIBLE THAT THERE MAY HAVE BEEN SOME PLATELET ACTIVATION, CAUSING AGGREGATION IN THE LRS CHAMBER, WHICH COULD RESULT IN A HIGHER THAN NORMAL AMOUNT OF WBCS TO BE COLLECTED WITH THE PLATELET PRODUCT. BASED ON THE AVAILABLE INFO, IT IS ALSO POSSIBLE THAT THIS LEUKOREDUCTION FAILURE COULD BE DONOR-RELATED. IT ALSO CANNOT BE RULED OUT 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 PROGRESS. 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. THE COMPLAINT WAS IDENTIFIED BY THE LAB AFTER THE PROCEDURE HAD ENDED. THEREFORE THE DISPOSABLE WAS UNAVAILABLE FOR RETURN. THERE WAS NO DONOR REACTION. NO MEDICAL INTERVENTION WAS REQUIRED. DONOR UNIT # (B)(4). THIS REPORT IS BEING FILED DUE TO A PRODUCT 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 CARIDIAN BCT 04T2114

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR