BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM 1 COOLING AND HEATING SYSEM

    MDR report key: 3994148 · Received July 24, 2014

    Report

    Report Number
    1828100-2014-00646
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE CARDIOPLEGIA MOTOR WAS RUNNING INTERMITTENTLY. THERE WERE NO ALARMS, THE UNIT JUST STOPPED WORKING. 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 PT. PER THE CLINICAL REVIEW ON (B)(6) 2014: IT WAS OBSERVED THAT THE COOLER HEATER UNIT CARDIOPLEGIA WATER PUMP WOULD INTERMITTENTLY WORK AND THEN STOPPED FUNCTIONING ALL TOGETHER. THIS WAS FOUND DURING A DOSE OF CARDIOPLEGIA WHEN IT WAS OBSERVED THE WATER TEMPERATURE DURING CARDIOPLEGIA DELIVERY WAS THIRTEEN DEGREES CELSIUS VERSUS THE USUAL FIVE DEGREES CELSIUS. NO ALARMS INDICATING AN ISSUE. AFTER THE DOSE WAS DELIVERED, THE WATER LINES THAT WERE CONNECTED TO THE CARDIOPLEGIA DISPOSABLE DEVICE WERE CLAMPED AND DISCONNECTED, AND A BACK-UP COOLER HEATER WAS BROUGHT TO THE OPERATING ROOM AND THIS BACK-UP COOLER HEATER WAS USED FOR THE REMAINDER OF THE PROCEDURE TO SUPPLY WATER TO THE CARDIOPLEGIA CIRCUIT COMPONENTS. THE ORIGINAL COOLER HEATER UNIT CONTINUED TO BE USED FOR ARTERIAL BLOOD COOLING AND WARMING. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY AND WITHOUT ASSOCIATED BLOOD LOSS. THERE WAS NO HARM REPORTED OR OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435318 TERUMO TCM 1 COOLING AND HEATING SYSEM TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 15747

    Patients

    Seq Age Sex Outcome Treatment
    1