BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 3862857 · Received February 20, 2014

    Report

    Report Number
    1828100-2014-00112
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    December 4, 2013
    Report Date
    January 28, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) ARRIVED TO PERFORM PREVENTATIVE MAINTENANCE (PM) ON THE COOLER HEATER UNIT. THE FSR TESTED THE UNIT AND COULD NOT DUPLICATE THE REPORTED ISSUE. THE FSR REPLACED THE CARDIOPLEGIA (CPG) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) BOARD AND TESTED. THE PM WAS COMPLETED PER PROCEDURE AND 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 USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CARDIOPLEGIA WORKS, BUT THE LIGHT WOULD NOT COME ON. THE COOLER HEATER UNIT CONTINUED TO FUNCTION. THE FRONT PANEL HAD NO LIGHT BUT PUMP CAME ON WHEN THE BUTTON WAS PRESSED AND THERE WAS NO ALARMS. THE DEVICE WAS NOT CHANGED OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OF OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106667 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