BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL RBC AND PLS SET

    MDR report key: 2083077 · Received April 26, 2011

    Report

    Report Number
    1722028-2011-00039
    Event Type
    Other
    Date Received
    April 26, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 29, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING SEVERAL PLASMA AND RBC COLLECTIONS FROM A SINGLE CUSTOMER, RBC WERE FOUND IN THE PLASMA PRODUCT. IT OCCURRED WITH DIFFERENT DONORS WITH DIFFERENT PRE-COUNT DATA, BUT THE SAME CARIDIANBCT DISPOSABLE LOT NUMBER. THE CUSTOMER CLAIMS THAT THERE WAS NO ALARM FROM THE MACHINE, THEREFORE THE CUSTOMER WAS NOT PROVIDED THE OPPORTUNITY TO RECOVER THE PLASMA COLLECTION BY USING THE 'SPILLOVER' FEATURE OF THE TRIMA DEVICE. PER THE CUSTOMER THE DEFECTIVE DISPOSABLES ARE NOT AVAILABLE FOR INVESTIGATION. CARIDIANBCT IS CONTINUING TO REQUEST FURTHER INFORMATION FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL RBC AND PLS SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 11S2107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other