BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL PLT, PLS, RBC SET

    MDR report key: 2220622 · Received July 14, 2011

    Report

    Report Number
    1722028-2011-00112
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE RUN DATA FILES (RDF) WERE ANALYZED. BASED ON AVAILABLE INFO IT IS POSSIBLE THAT THE NUMEROUS ACCESS PRESSURE ALERTS COULD HAVE DISRUPTED THE STEADY-STATE OF THE SYS AND COULD HAVE CONTRIBUTED TO THE HIGHER THAN EXPECTED WBC COUNT. IT IS ALSO POSSIBLE THAT THIS LEUKOREDUCTION FAILURE COULD BE DONOR RELATED. 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 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. DONOR UNIT #(B)(4). THIS REPORT IS BEING FILED DUE TO A DEVICE MALFUNCTION THAT HAS 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 CARIDIANBCT 04T3125

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other