BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 2619061 · Received June 29, 2009

    Report

    Report Number
    1722028-2009-00006
    Event Type
    Other
    Date Received
    June 29, 2009
    Date of Event
    June 8, 2009
    Report Date
    June 29, 2009
    Manufacturer
    CARIDIANBCT, INC.
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR SERIOUS INJURY FROM AN AIR EMBOLISM CAUSED BY USE ERROR. THE OPERATOR FAILED TO FOLLOW THE INSTRUCTIONS IN THE USER INTERFACE WHICH WOULD REQUIRE LOADING AND PRIMING THE TUBING SET PRIOR TO DONOR CONNECTION AND VENIPUNCTURE. THE OPERATOR THEN IGNORED TWO ALARMS. THIS WAS VERIFIED BY THE DEVICE OPERATOR'S SUPERVISOR. A SERVICE CALL WAS PLACED FOR THE DEVICE. THE SERVICE TECHNICAL CONFIRMED THAT R-1 PRESSURE ALARMS WERE RECEIVED APPROXIMATELY 30 SECONDS APART DURING THE INITIATION OF THE RUN IN QUESTION. HE ALSO VERIFIED THAT THE APS, CPS, AND RBC DETECTOR CALIBRATIONS WERE WITHIN SPECIFICATIONS. THE UPPER AND LOWER LEVEL SENSORS WERE VERIFIED AS FUNCTIONING PER SPECIFICATIONS AND AN AUTOTEST, LOAD, PRIME AND SALINE RUN WERE PERFORMED WITH NO ISSUES. AN ANALYSIS OF THE RUN DATA FILE INDICATED THAT AFTER THE FIRST ALARM, THE OPERATOR PRESSED "CONTINUE". AFTER THE SECOND ALARM, THE OPERATOR PRESSED "UNLOAD". THE MACHINE DID NOT MAKE IT INTO THE BLOODRUN SUBSTATE, SO IT NEVER INCREMENTED THE RETURN VOLUME COUNTER. DURING CASSETTE LOAD, THE RETURN PUMP WAS COMMANDED TO 150 ML/MIN. DURING THE EVACUATEBAGS SUBSTATE, THE RETURN PUMP IS COMMANDED TO 90 ML/MIN. THE MACHINE GENERATED THE "PRESSURE DETECTED DURING BAG EVACUATION" ALARM BECAUSE IT DETECTED THE ACCESS PRESSURE SENSOR (APS) HAD EXCEEDED 50 MMHG. THE SECOND ALARM WAS GENERATED WHEN THE PRESSURE ON THE APS HAD READ 65.8 MMHG. THE RETURN PUMP RAN FOR APPROXIMATELY 24 SECONDS DURING THE "LOAD CASSETTE" SUBSTATE (150 ML/MIN), AND ONLY A COMBINED 9.6 SECONDS (APPROXIMATELY) DURING THE "EVACUATEBAGS" SUBSTATE. THEORETICAL 37.2 ML. OF AIR. CONCLUSIONS: THE DEVICE WAS FOUND TO BE OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE DEVICE OPERATOR PERFORMED THE VENIPUNCTURE ON A DONOR PRIOR TO LOADING THE CASSETTE OF THE TUBING SET. THE OPERATOR THOUGHT THAT THE SET WAS ALREADY LOADED. THE OPERATOR PRESSED CONTINUE THINKING SHE WAS STARTING THE PROCEDURE, BUT THIS WAS ACTUALLY LOADING THE TUBING SET. THERE WERE NO SOLUTIONS SPIKED AT THIS TIME, CREATING THE POTENTIAL FOR AN AIR EMBOLISM. THE OPERATOR THEN RECEIVED AN ALARM, BUT DIDN'T READ THE USER INTERFACE SCREEN. THE OPERATOR THOUGHT IT WAS A DRAW PRESSURE LOW ALARM AND PROCEEDED TO CHECK THE VENIPUNCTURE. OTHER STAFF NOTICED SOME AIR POSSIBLY IN THE LINE AND THE PROCEDURE WAS ENDED ABOUT 6 MINUTES INTO THE RUN. AFTER DISCONTINUATION OF THE AUTOMATED COLLECTION, A UNIT OF WHOLE BLOOD WAS MANUALLY DRAWN FROM THE DONOR. THE DONOR APPARENTLY HAD A REACTION RELATED TO THE WHOLE BLOOD DONATION AND CARE WAS GIVEN PER THE DONOR CENTER'S SOP. THE DONOR SUBSEQUENTLY LEFT THE CENTER FEELING FINE. THE MEDICAL DIRECTOR WAS LATER NOTIFIED AND CALLED THE DONOR TO VERIFY THAT THE DONOR WAS OK AND THE DONOR WAS STILL DOING FINE.

    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, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other