BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 1972833 · Received January 14, 2011

    Report

    Report Number
    1722028-2010-00086
    Event Type
    Other
    Date Received
    January 14, 2011
    Date of Event
    July 6, 2009
    Report Date
    January 14, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIELD DIAGNOSTIC/CORRECTION: THE SERVICE REP FOUND THE COAXIAL CABLE AND THE WAND OF THE EQUIPMENT WAS FAULTY; HE REPLACED BOTH. INVESTIGATION: THE HEAD ASSEMBLY AND THE COAXIAL CABLE WERE VISUALLY INSPECTED AND INSTALLED IN A TEST TRIMA AND RUN THROUGH A TEST PROCEDURE WITH NO PROBLEMS FOUND. A PM PROCEDURE WAS PERFORMED THE SAME DAY THAT THIS FAILURE WAS INVESTIGATED AND NO OTHER ISSUES WERE FOUND WITH THE EQUIPMENT. TRENDING INDICATES THAT THIS IS AN INFREQUENT ISSUE BY REVIEWING A FORMAT DETAIL CODE ORDER REPORT FOR THIS FAILURE MODE. THERE HAVE ONLY BEEN SEVEN OTHER REPORTS OF SHOCK/BURN IN ALL THE MILLIONS OF TRIMA PROCEDURES THAT HAVE BEEN PERFORMED. CONCLUSION: UNDETERMINED; IT IS POSSIBLE THAT THERE WAS AN INTERMITTENT CONNECTION ISSUE WITH THE COAXIAL CABLE AND THE SEALER HEAD, OR THAT THE OPERATOR WAS USING SEALER TOO CLOSE TO THEIR HAND, HOWEVER, SINCE THE PART EVAL REVEALED NO ISSUES NEITHER OF THESE POSSIBILITIES CAN BE PROVEN.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVALUATION PROCESS THAT WERE PROMPTED BY AN FDA INSPECTION. THE CUSTOMER REPORTED THAT ONE OF THE OPERATOR'S OF THE TRIMA SEALSAFE RECEIVED A MINOR SHOCK/BURN. MULTIPLE ATTEMPTS TO OBTAIN PT IDENTIFIER INFO WERE UNSUCCESSFUL. THIS REPORT IS BEING FILED DUE TO A SHOCK CAUSED BY FAULTY CABLE.

    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 UNK Required Intervention