BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 2905750 · Received January 9, 2013

    Report

    Report Number
    1722028-2012-00936
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 14, 2012
    Report Date
    December 2, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RUN DATA FILE WAS ANALYZED FOR THIS EVENT. ROOT CAUSE: THE ANALYSIS OF THE RUN DATA FILE DID NOT FIND A CONCLUSIVE CAUSE FOR THE HIGHER THAN EXPECTED WBC CONTENT REPORTED FOR THIS COLLECTION. THE SIGNALS IN THE RUN DATA FILE INDICATE IT IS POSSIBLE,THOUGH NOT CONCLUSIVE, THAT THE PLASMA LINE MAY HAVE BEEN PARTIALLY OCCLUDED NEAR THE END OF THE PROCEDURE. IF THE PLASMA LINE DOES NOT CONTRIBUTE PROPERLY TO THE PLATELET PUMP, IT COULD CAUSE THE FLOW THROUGH THE LRS CHAMBER TO BE HIGHER THAN THE SYSTEM EXPECTS, POSSIBLY ALLOWING SOME WBCS TO ESCAPE. ORIENTATION OF THE HEX IN THE HEX HOLDER MAY CONTRIBUTE TO THE ABOVE. AN INTERNAL CAPA HAS BEEN INITIATED TO EVALUATE REPORTS OF ELEVATED WBC COUNTS RELATED TO PLASMA LINE OCCLUSIONS.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RUN DATA FILE WAS ANALYZED FOR THIS EVENT. THE ANALYSIS OF THE RUN DATA FILE DID NOT FIND ANY CONCLUSIVE CAUSE FOR THE HIGHER THAN EXPECTED WBC CONTENT REPORTED FOR THIS COLLECTION. IT IS POSSIBLE THAT THE NUMEROUS ACCESS PRESSURE ALERTS AND ADJUSTMENTS COULD HAVE DISRUPTED THE STEADY STATE OF THE SYSTEM AND COULD HAVE CONTRIBUTED TO THE HIGHER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT. IT ALSO CANNOT BE RULED OUT THAT A SAMPLING,CALCULATION, OR OTHER PROCESS ERROR COULD HAVE CONTRIBUTED TO THE HIGHER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT. ADDITIONALLY, BASED ON THE AVAILABLE INFORMATION, IT CANNOT BE RULE OUT THAT THIS LEUKOREDUCTION FAILURE COULD BE DONOR RELATED. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED

    Description of Event or Problem · 1

    DONOR UNIT # (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(6). DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO A DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11971 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA, RBC SET GKT TERUMO BCT 10U1221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other