BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 3012961 · Received March 1, 2013

    Report

    Report Number
    1828100-2013-00199
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) CONFIRMED THE COMPLAINT. THE ICE BLOCK HAS FROZEN NEARLY 90% OF TANK AND WAS FROZEN SOLID THE ENTIRE DEPTH OF THE FRONT HALF. FLOW WAS WORKING, BUT VOLUME AVAILABLE WAS MINIMAL. THE FSR DEFROSTED THE UNIT. FLOWS WERE STILL WEAK AND THERE WAS NOTICEABLE SEDIMENT IN BOTH TANKS. THE FSR DRAINED UNIT AND OPENED BOTTOM LINES; THE VALVES AND LINES WERE CLEAR. THE FSR REPLACED THE PRESSURE SWITCH BECAUSE IT WAS NOT OPERATING. SEE RELATED MDR #1828100-2013-00220. HE REPLACED VALVES 1 AND 2 ON THE UNIT. WITH THE COMPONENTS REPLACED AND A FULL INSPECTION PERFORMED, THE UNIT OPERATES TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CARDIOPLEGIA WOULD NOT COOL AND THERE WAS LITTLE FLOW. THE PERFUSIONIST ALSO NOTED THAT THE LARGE ICE TANK WAS FROZEN SOLID. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90351 TERUMO TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEM CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1