BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)

    MDR report key: 7128487 · Received December 19, 2017

    Report

    Report Number
    1828100-2017-00575
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 27, 2017
    Report Date
    February 13, 2018
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED. DURING LABORATORY ANALYSIS, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) MEASURED THE FUSES USING A MULTIMETER WHICH WERE FOUND TO BE OPENED AND THE FITTING WAS BROKEN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). AS PER THE FIELD SERVICE REPRESENTATIVE (FSR), THE COMPLAINT CONDITION WAS THE RESULT OF THREE BLOWN FUSES ON THE CPG RELAY BOARD. MOISTURE WAS NOTED TO BE AROUND THE CPG TANK. THE FSR FOUND A SPLIT BULKHEAD FITTING ON THE OUTLET OF THE CPG TANK. THE FSR FOUND THAT WAS THE SOURCE OF THE MOISTURE AND BELIEVED THAT TO BE THE CAUSE OF BLOWN FUSES. FSR REBUILT THE CPG CIRCUIT WITH NEW PUMP, NEW VALVES, AND ALL NEW FITTINGS. THE UNIT OPERATED TO THE MANUFACTURER'S SPECIFICATIONS. THE SUSPECT COMPONENTS WILL BE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. THIS COMPLAINT IS RELATED TO (B)(4) / MEDWATCH #1828100-2017-00552.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CARDIOPLEGIA (CPG) PUMP ON THE UNIT STOPPED WORKING. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: DURING A CPB PROCEDURE ON (B)(6) 2017, THE TEAM AT THE USER FACILITY HAD A HEATER COOLER STOP WORKING. THE CPG PUMP ON THE HEATER COOLER QUIT WORKING. A PREVIOUS OCCURRENCE OF CPG PUMP FAILURE WAS SEEN ON (B)(6) 2017 AND REPAIRED ON (B)(6) 2017. THIS OCCURRENCE WAS DURING THE MIDDLE OF THE PROCEDURE, AND THE PERFUSIONIST NEEDED THE CPG SOLUTION TO BE COLD, THEREFORE THE TEAM SWAPPED OUT THE HEATER COOLER WITH ANOTHER UNIT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM, NOR BLOOD LOSS ASSOCIATE WITH THE EVENT, AND AS NOTED ABOVE THE EXCHANGE OF THE HEATER COOLER WITH ANOTHER UNIT DID NOT CAUSE A DELAY IN THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911360 SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING DWC TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 4415

    Patients

    Seq Age Sex Outcome Treatment
    1