BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 1940953 · Received December 17, 2010

    Report

    Report Number
    1722028-2010-00075
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    April 14, 2009
    Report Date
    December 17, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RISK ANALYSIS: IN THIS PARTICULAR CASE, ACCORDING TO WHAT THE OPERATOR TOLD THE MGR WHO RELAYED THE INFO TO CARIDIANBCT, THE VENIPUNCTURE WAS PERFORMED AFTER THE CASSETTE WAS LOADED BUT BEFORE AC PRIME WAS COMPLETED. WHEN THE CASSETTE IS LOWERED IT PERFORMS A SERIES OF AIR EVACUATIONS AND SET TESTS. AFTER THIS POINT THE TRIMA PROMPTS THE OPERATOR TO CLOSE THE DONOR LINE CLAMPS AND THE SAMPLE BAG LINE CLAMPS BEFORE MOVING ON TO THE AC PRIME. THIS IS WHEN THE OPERATOR STATES THEY ATTACHED THE DONOR. ACCORDING TO SUPPORT/CLINICAL SPECIALIST FOR AUTOMATED COLLECTIONS, (B)(6), AT THIS POINT THERE IS NO DANGER OF THE OPERATOR RECEIVING AN AIR EMBOLISM SINCE THE AIR EVACUATION HAS BEEN COMPLETED, HOWEVER BY ATTACHING THE DONOR EARLY THE OPERATOR HAS RELEASED PRESSURE FROM THE SET AND IT WILL NOT PASS AC PRIME, WHICH IS WHAT OCCURRED IN THIS PROCEDURE. ANY AIR LEFT IN THE SET DURING AC PRIME (IN THE AC LINE) IS PUSHED BY THE AC PUMP INTO THE SET ITSELF AND THROUGH THE LEVEL SENSOR, WHICH ALARMS WITH AN AC PRIME FAILURE BEFORE ANY AIR CAN REACH THE DONOR. RDF ANALYSIS CONFIRMS THAT THE EQUIPMENT HAD COMPLETED THE PROCESS TO THE AC PRIME SCREEN (WHEN AC IS ATTACHED) WITH NO ISSUES, BUT RECEIVED AN AC NOT DETECTED ALARM AND THEN ON SECOND ATTEMPT THE RUN FAILS DUE TO THE ACCESS PRESSURE SENSOR NOT REACHING TARGET PRESSURE. CONCLUSION: OPERATOR ERROR. TRIMA V6 SOFTWARE ADDED WARNING SCREENS REGARDING HAVING THE PT CONNECTED DURING AIR EVACUATION AND TO REDUCE THE AMOUNT OF AIR PUSHED OUT DURING PUMP LOAD/UNLOAD.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS. WE HAVE CHANGED OUR PROCESS TO BETTER ALIGN WITH CURRENT AGENCY POLICY. (B)(6) IS REVIEWING A DONOR RECORD FROM (B)(6) 2009. FROM HER REVIEW OF THE DONOR RECORD, IT APPEARS THAT THE VENIPUNCTURE WAS PERFORMED ON THE DONOR AND THE SAMPLES WERE COLLECTED FROM THE SAMPLE POUCH BEFORE AC PRIME HAD BEEN STARTED. SHE IS WANTING TO KNOW IF THERE IS A POSSIBILITY THAT THE AIR COULD HAVE BEEN GIVEN TO THE DONOR. CUSTOMER IS NOT ALLEGING A DEFICIENCY WITH EITHER THE MACHINE OR DISPOSABLE. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR AIR TO DONOR.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1