BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 2121940 · Received June 1, 2011

    Report

    Report Number
    1722028-2011-00146
    Event Type
    Other
    Date Received
    June 1, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 6, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK010006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DISPOSABLE BRAND NAME: TRIMA ACCEL PLT, PLS, RBC SET. DISPOSABLE MANUFACTURE DATE: 03/2011. THE DISPOSABLE SET INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED. EQUIPMENT: INVESTIGATION: A SERVICE CALL WAS PLACED FOR THIS MACHINE. THE SERVICE REP CHECKED THE RBC DETECTOR AND FOUND IT WAS WITHIN SPECIFICATIONS. HE RAN A FULL AUTOTEST WITH NO ISSUES FOUND. THE RUN DATA FILES WERE ANALYZED FOR THIS INCIDENT. THE SIGNALS IN THE RUN DATA FILES INDICATE THAT THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: UNDETERMINED; FROM THE INFORMATION AVAILABLE THERE DOES NOT SEEM TO BE A HEMOLYSIS ISSUE AND THE DEVICE PERFORMED AS INTENDED AND PER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RED DISCOLORATION IN THE PLASMA AND PLATELET PRODUCTS DURING A PLATELET/PLASMA COLLECTION PROCEDURE AT 32 MINUTES. THE RUN WAS ENDED. THE CUSTOMER NOTED A KINK IN THE RBC LINE ON THE DISPOSABLE SET AND WAS QUESTIONING WHY SHE DID NOT RECEIVE ANY ALARMS OR ALERT MESSAGES INDICATING THE POTENTIAL RBC CONTAMINATION IN THE PLATELET LINE, OR INDICATING INCREASED PRESSURE DUE TO THE KINK IN THE LINE. THE SUPERVISOR STATES THAT THE OPERATOR DESCRIBED A LINE OF RBCS GOING UP THE PLATELET AND PLASMA COLLECTION LINES. THE RUN WAS ENDED WITHOUT RINSEBACK. THE CUSTOMER IS ALLEGING DEFICIENCY WITH THE DISPOSABLE AND THE EQUIPMENT. THE DONOR WAS MONITORED FOR 30 MINUTES POST-PROCEDURE. HIS VITALS WERE STABLE AND NO ADVERSE EFFECTS WERE OBSERVED. THE DONOR WAS ALSO CONTACTED THE NEXT DAY TO CHECK ON ANY ILL EFFECTS, AND HE REPORTED THAT HE HAD NONE. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 917000000 03T3225

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other