BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 4172361 · Received October 9, 2014

    Report

    Report Number
    1828100-2014-00857
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE FIELD SVC REP (FSR) RAN THE DEVICE FOR ONE HR WITHOUT ANY FAILURES. A CALIBRATION CHECK WAS COMPLETED SUCCESSFULLY WITHOUT HAVING TO MAKE ANY ADJUSTMENTS. IF ADD'L INFO 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 SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE COOLER HEATER UNIT WOULD REVERT TO "STANDBY" MODE WHILE IN THE MAINTAIN MODE AND "REWARM" MODE. THE UNIT NEVER FAULTED DURING THE SURGICAL PROCEDURE. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, AND NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636788 TERUMO TCM II COOLING AND HEATING SYSTEM TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1