BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL PLT, PLS, RBC FRENCH SET

    MDR report key: 2111273 · Received May 18, 2011

    Report

    Report Number
    1722028-2011-00099
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVAL, ROOT CAUSE, AND CORRECTIVE AND PREVENTATIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THERE WAS WHITE CELL CONTAMINATION IN PLATELET PRODUCT WITH THE SAME SERIAL NUMBER AND NO LEUKOREDUCTION FLAG DURING OQ OF THE SYSTEM. DON: (B)(6) 2011.

    Additional Manufacturer Narrative · 2

    (B)(4). INVESTIGATION EVAL, ROOT CAUSE, AND CORRECTIVE AND PREVENTATIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 2

    THERE WAS WHITE CELL CONTAMINATION IN PLATELET PRODUCT WITH THE SAME SERIAL NUMBER AND NO LEUKOREDUCTION FLAG DURING OQ OF THE SYSTEM. DON (B)(6) 2011.

    Additional Manufacturer Narrative · 3

    (B)(4). INVESTIGATION EVAL, ROOT CAUSE, AND CORRECTIVE AND PREVENTATIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 3

    THERE WAS WHITE CELL CONTAMINATION IN PLATELET PRODUCT WITH THE SAME SERIAL NUMBER AND NO LEUKOREDUCTION FLAG DURING OQ OF THE SYSTEM. DON (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other
    2 25 YR Other
    3 24 YR Other