BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIMA ACCEL ENHANCED PPC, PL, RBC SET

    MDR report key: 1973822 · Received January 14, 2011

    Report

    Report Number
    1722028-2010-00096
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    September 28, 2009
    Report Date
    January 14, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DONOR INJURY IS BEING ALLEGED IN THIS EVENT. THE NURSE PERFORMED NEEDLE REMOVAL WHEN SHE OBSERVED AIR IN THE TUBING SET MOVING TOWARD THE DONORS. NONE OF THIS AIR VOLUME IS CLAIMED TO HAVE REACHED THE DONORS. IMPROPER CLAMPING DURING DISPOSABLE TESTS IS THE LEADING REASON FOR RECEIVING THE "FAILURE TO PRESSURIZE INLET" ALARM. THE TRIMA MACHINE SCREENS THAT CAN BE ACCESSED FOLLOWING THIS ALARM RECOMMEND MITIGATION STEPS FOR THE OPERATOR TO PERFORM TO ENSURE NO RESIDUAL AIR REMAINS IN THE SAMPLE BAG. FAILURE OF THE OPERATOR TO PROPERLY EXPEL THE AIR TRAPPED IN THE SAMPLE BAG FROM A SINGLE EVENT OF IMPROPER CLAMP CLOSURE DURING DISPOSABLE TESTS WOULD RESULT IN A VOLUME OF APPROX 12ML. NO ADVERSE HEALTH EFFECTS HAVE BEEN OBSERVED AS NO AIR WAS DELIVERED TO THE PT IN THE REPORTED INCIDENT. A VISUAL EVALUATION OF THE TUBING SET REVEALED NO DEFECTS. THE TRIMA DOES NOT MONITOR FOR A PARTIALLY INFLATED OPEN SAMPLE BAG AS THE ALARM SCREENS FOLLOWING THE "FAILURE TO PRESSURIZE INLET" ALARM INSTRUCTS THE OPERATOR TO EXPRESS OUT THE IMPROPERLY PLACED AIR FROM THE SAMPLE BAG OUT THE DONOR ACCESS NEEDLE BEFORE CONTINUING WITH DISPOSABLES TESTS, AC PRIME AND VENIPUNCTURE. IF PROPER SCREEN INSTRUCTIONS ARE FOLLOWED, NO AIR IS PRESENT IN THE INLET COIL SYSTEM DURING DONOR CONNECT. CONCLUSION: OPERATOR ERROR CAUSED THIS EVENT.

    Description of Event or Problem · 1

    (B)(4). DURING PRIMING, THE CUSTOMER RECEIVED AN ALARM: PRESSURE TEST FAILURE. THE CUSTOMER STATED "ALARM" WAS REMOVED BY OPENING THE PRODUCT (ALSO REFERRED TO AS SAMPLE) BAG. AFTER THE ALARM WAS REMOVED, THE DONOR WAS CONNECTED. WHEN THE NEEDLE WAS CONNECTED AND THE CLAMP WAS OPENED, THE NURSE NOTICED AIR BUBBLE IN RETURN LINE GOING TOWARD THE PT - SHE IMMEDIATELY TOOK NEEDLE OUT OF THE PT. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR INJURY FROM AIR TO DONOR CAUSED BY OPERATOR ERROR. DONOR IDENTIFIER INFORMATION COULD NOT BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL ENHANCED PPC, PL, RBC SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 01R3129

    Patients

    Seq Age Sex Outcome Treatment
    1