BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 3231118 · Received July 12, 2013

    Report

    Report Number
    1828100-2013-00653
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS CONFIRMED BY THE FIELD SERVICE REPRESENTATIVE (FSR). THE FSR FOUND A LOOSE HOSE CLAMP IN THE CARDIOPLEGIA PLUMBING CIRCUIT. WITH THE HOSE CLAMP TIGHTENED AND PREVENTATIVE MAINTENANCE COMPLETE, THE UNIT OPERATED 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

    THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THERE WAS A WATER LEAK IN THE CARDIOPLEGIA CIRCUIT ON THE COOLER HEATER UNIT. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322284 TERUMO TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1