BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 2895202 · Received January 3, 2013

    Report

    Report Number
    1722028-2013-00001
    Date Received
    January 3, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 6, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. A SERVICE CALL WAS PLACED FOR THE TRIMA ACCEL SYSTEM. THE MACHINE PASSED AUTO TESTS. ALSO, NO ISSUES WERE NOTED ASSOCIATED WITH THE PLASMAVALVE AND PLASMA PUMP. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. BASED ON THE RDF ANALYSIS, THE ROOT CAUSE COULD BE RELATED TO THE PLASMA PUMP NOT OCCLUDING THE PLASMA PUMP HEADER PROPERLY. THERE WERE SIGNALS IN THE RDF THAT SUGGEST THE RESERVOIR VOLUMES DID NOT LOOK NORMAL. THERE ARE A FEW THINGS THAT MAY EXPLAIN THIS. ONE BEING THAT SOME EXTRA VOLUME IS BEING ROUTED TO THE PLASMA BAG LEADING TO LESS VOLUME ENTERING THE RESERVOIR. THERE WAS ALSO A 'MOTOR HARDWARE FAILURE' ALARM DURING THE LOADING OF THE KIT. ACCORDING TO THE RDF, THIS OCCURRED DUE TO THE PLASMA PUMP. POSSIBLE CAUSES MAY INCLUDE: DEFECTIVE PUMP MOTOR. DEFECTIVE PUMP. MISLOADED PUMP HEADER. MISALIGNED PUMP RACEWAY. IF A PUMP HEADER IS NOT LOADED PROPERLY, THAT CAN LEAD TO OVER-DELIVERY OF VOLUME. IN THIS CASE, IT MAY LEAD TO OVER-DELIVERING OF PLASMA TO THE PLASMA BAG, WHICH WOULD EXPLAIN THE RESERVOIR SHIFTS SEEN IN THE RDF. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. IT IS BELIEVED THE VOLUME REMOVAL ERROR WAS CAUSED BY LACK OF OCCLUSION IN THE PLASMA PUMP. THIS LACK OF OCCLUSION LED TO REMOVING 5 ML TOO MUCH PLASMA EACH DRAW CYCLE DURING THE COURSE OF PLASMA COLLECTION. IN THIS CASE THERE WERE ABOUT 30 CYCLES DURING PLASMA COLLECTION RESULTING IN APPROXIMATELY 150 ML MORE THAN THE TARGETED PLASMA REMOVAL. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AT THE END OF THE PROCEDURE, THEY NOTICED THAT THE PLASMA COLLECT VOLUME WAS HIGHER THAN EXPECTED. DURING POST COLLECTION, THE PLASMA COLLECT VOLUME MEASURED 953ML COMPARED TO THE EXPECTED PREDICTED VOLUME OF 600ML, WHICH IS MORE THAN 15% OF THE DONOR'S TOTAL BLOOD VOLUME (TBV). PATIENT IDENTIFIER AND AGE ARE NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR DEATH OR INJURY OCCURRED.

    Description of Event or Problem · 1

    THE PATIENT'S IDENTIFICATION AND AGE WERE NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3019 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA, RBC, PAS, TLR SET GKT TERUMO BCT 09U3214

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR