BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRA OPTIA

    MDR report key: 3170204 · Received June 14, 2013

    Report

    Report Number
    1722028-2013-01248
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK120012
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. THE NURSE WHO RECEIVED THE SHOCK WAS CONTACTED AND IT WAS CONFIRMED THAT NO INJURY OR MEDICAL INTERVENTION WAS NEEDED AS A RESULT OF THE SHOCK OR THE FLUID SPRAYING OUT OF THE TUBING SET. 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 OR WHAT FEELS LIKE A SHOCK. 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 ARCHING. 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 THE POSSIBILITY OF RECEIVING A RADIO FREQUENCY BURN. ROOT CAUSE: A ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE TERUMO BCT FIELD SPECIALIST REPLACED THE CUSTOMER'S SEAL SAFE. THE NEW SEAL SAFE WAS TESTED TO VERIFY PROPER FUNCTIONING. INVESTIGATION, EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDE

    Description of Event or Problem · 1

    PATIENT (OPERATOR) GENDER, AGE AND WEIGHT ARE NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SEAL SAFE IS SHOCKING THE NURSES AND IS CUTTING THROUGH THE TUBING, CAUSING FLUID TO SPRAY OUT. IT IS NOT KNOWN AT THIS TIME IF ANY MEDICAL INTERVENTION WAS NEEDED FOR THE SHOCKS, OR IF ANY BLOOD EXPOSURE OCCURRED AS A RESULT OF THE FLUID SPRAYING OUT OF THE TUBING. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR DEATH OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271401 SPECTRA OPTIA SPECTRA OPTIA APHERESIS SYSTEM LKN TERUMO BCT 000000000000061000

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR