BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA SEALSAFE

    MDR report key: 2142984 · Received June 21, 2011

    Report

    Report Number
    1722028-2011-00187
    Event Type
    Other
    Date Received
    June 21, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE OPERATOR WAS SEALING THE SAMPLE POUCH AFTER THE DONOR HAD BEEN ATTACHED TO THE SET. SHE HAD ALSO JUST USED ALCOHOL GEL TO CLEAN HER HANDS AND SO IT WAS HIGHLY LIKELY THAT HER HANDS WERE NOT COMPLETELY DRY BEFORE OPERATION. THE SERVICE REP CHECKED THE SEAL SAFE AND FOUND IT OPERATIONAL WITH NO FAULTS OR ISSUES. ROOT CAUSE: LIKELY THE CAUSE OF THE SHOCK WAS DUE TO MOISTURE ON THE OPERATOR'S HANDS AND/OR SHE HAD HER HANDS TOO CLOSE TO THE SEALER JAWS, HOWEVER, THIS CANNOT BE DEFINITIVELY DETERMINED. CORRECTIVE ACTION: BY PLACING ONE'S FINGER NEXT TO THE CUTTER/SEALER HEAD JAWS DURING OPERATION OF THE UNIT, THE OPERATOR CAN RECEIVE AN RF BURN. THE TRIMA OPERATOR'S MANUAL CAUTIONS THE OPERATOR TO ENSURE THAT THE SEALING HEAD AND TUBING ARE FREE OF MOISTURE BEFORE OPERATING THE SEAL SAFE TO AVOID POSSIBLE ELECTRICAL ARCING. IN ADDITION, THE MANUAL WARNS THE USER TO NOT PLACE FINGERS WITHIN 1 INCH OF THE SEAL SAFE'S SEALING JAWS WHILE SEALING TO AVOID POSSIBILITY OF RECEIVING A RADIO FREQUENCY BURN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN OPERATOR RECEIVED A SMALL SHOCK WHILE USING THE SEALSAFE. NO MEDICAL INTERVENTION WAS NECESSARY. (B)(4). THIS REPORT IS BEING FILED DUE TO ELECTRIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA SEALSAFE AUTOMATED BLOOD CELL SEPARATOR LKN CARIDIANBCT 917100000

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other