BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 3912788 · Received May 14, 2014

    Report

    Report Number
    1828100-2014-00382
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 21, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS UNIT WAS NEVER USED IN ANY CASES. THE USER WAS ATTEMPTING TO USE AS A BACK UP UNIT. THIS UNIT NEVER STARTED WORKING PROPERLY SO THEY SENT IT TO THE BIOMED. THE FIELD SERVICE REPRESENTATIVE (FSR) VERIFIED POOR FLOW FROM THE MAIN HANSEN VALVES. THE FSR FOUND THE INLINE FILTER WAS PLUGGED WITH MINERAL DEPOSITS. THE FSR CLEANED OUT THE FILTER AND FLUSHED THE MAIN HANSEN VALVES, AND PROPER FLOW WAS RESTORED. THE FSR COMPLETED PREVENTATIVE MAINTENANCE (PM) AND A RELEASE TEST. 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

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THERE WAS LOW FLOW WITH THE COOLER HEATER UNIT, AS IF THE SMALL TANK RUNS ALL THE TIME. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. 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
    288390 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