BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 1952157 · Received December 29, 2010

    Report

    Report Number
    1722028-2010-00068
    Event Type
    Other
    Date Received
    December 29, 2010
    Date of Event
    November 12, 2009
    Report Date
    December 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SOURCE: CUSTOMER REPORTED AN OPERATOR RECEIVED A SHOCK WHILE USING THE TRIMA SEAL SAFE. OPERATOR REPORTS THAT HANDS WERE DAMP. RISK ANALYSIS: PER CARIDIANBCT (B)(4) - BURN FROM A SEAL SAFE TUBE SEALER IS ESTIMATED AT A LOW RISK OF TEMPORARY, REVERSIBLE INJURY. FIELD DIAGNOSIS/CORRECTION: THE SEAL SAFE DEVICE WAS TESTED BY THE CUSTOMER ENGINEER. NO PROBLEMS WERE FOUND WITH THE DEVICE. A POSSIBLE HAIRLINE CRACK ON THE CABLE INSULATION WAS NOTED AND THEREFORE THE SEALER HEAD WAS REPLACED AS A PRECAUTIONARY MEASURE. THE PART WAS NOT REQUESTED FOR RETURN AS THE ROOT CAUSE IS BELIEVED TO BE DUE TO MOISTURE ON THE HANDS DURING SEALING. INVESTIGATION: A KNOWN HAZARD ASSOCIATED WITH THE USE OF THE SEAL SAFE IS RADIO FREQUENCY (RF) BURNS TO THE OPERATOR. 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 (9-5). 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 (9-5, 9-6). ROOT CAUSE: OPERATOR ERROR-HANDS WERE WET AND POTENTIALLY TOO CLOSE TO THE SEALER JAWS DURING SEALING. CORRECTIVE/PREVENTIVE ACTION: TRENDS WILL CONTINUE TO BE MONITORED ACCORDING TO THE PREVENTIVE AND CORRECTIVE ACTION SECTION OF THE COMPLAINT SOP. BASED ON THE LOW RISK REFERENCED IN THE HEALTH HAZARD ANALYSIS AND EXISTING INFO CONTAINED IN THE OPERATOR'S MANUAL, NO ADDITIONAL ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVALUATION PROCESS. WE HAVE CHANGED OUR PROCESS TO BETTER ALIGN WITH CURRENT AGENCY POLICY. OPERATOR GOT A "SHOCK" FROM THE SEAL HEAD. OPERATOR HAD FINGER AROUND THE BACK OF THE SEAL SAFE HEAD WHEN SEALING AND BELIEVES HER HANDS WERE DAMP. SEAL SAFE HEAD EXAMINED AND SPLASH MARK VISIBLE ON BACK OF ELEMENT BUT POSSIBLE HAIRLINE CRACK ON INSULATION ALSO VISIBLE. SEAL SAFE HEAD REPLACED AS A PRECAUTION. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA AUTOMATED BLOOD COLLECTION SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 917100000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other