BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 3111872 · Received May 7, 2013

    Report

    Report Number
    1828100-2013-00454
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS RELATED TO MDR #1828100-2013-00351. THE SUBSIDIARY FIELD SERVICE REP (FSR) WENT TO THE HOSPITAL TO REPLACE THE ELBOW. THE FSR TESTED THE ICE COMPRESSOR AGAIN, BUT IT DID NOT START AFTER FIVE MINS, WE DID THE SAME EVAL ON (B)(4) 2013 (MDR #1828100-2013-00351). THE ICE COMPRESSOR WAS STARTED AND RAN AGAIN. THE FSR DECIDED TO CHECK THE UNIT THE NEXT DAY. UPON ARRIVAL THE FOLLOWING DAY, THE FSR FOUND A GROUP OF AIR BUBBLES FROM THE AIR COMPRESSOR IN THE LARGE TANK BUT THE ICE COMPRESSOR WOULD NOT START. WHEN THE PRESSURE SWITCH WAS PRESSED THE THIRD TIME, THE ICE COMPRESSOR FINALLY STARTED AND RAN. THE FSR THOUGHT THE 1/4 INCH OD TUBING WAS TOO LONG AND CUT AROUND 60CM OFF, BUT DID NOT SOLVE THE PROBLEM. THE FSR INSTALLED THE NEW PRESSURE SWITCH BOARD AND COMPRESSOR DELAY BOARD. IT OPERATED AGAIN, BUT WHEN WE TRIED THE THIRD TIME, THE SAME PROBLEM OCCURRED AGAIN. THE FSR ALSO CHECKED THE 1/4 INCH OD TUBING AND AIR COMPRESSOR. THE COMPONENTS SEEMED TO BE GOOD. WE BLEW AIR WITH MOUTH INTO THE 1/4 INCH TUBING, AIR BUBBLES WERE FOUND IN THE LARGE TANK. THE FSR FOUND THAT HE COULD PRESS THE PRESSURE SWITCH AGAIN AND AGAIN (LESS THAN FOUR TIMES) TO START THE COMPRESSOR.

    Description of Event or Problem · 1

    THE FIELD SERVICE REP (FSR) REPORTED THAT DURING FIELD SERVICE INSTALLATION OF THE DEVICE, THE COMPRESSOR WOULD NOT STARTUP AFTER FIVE MINS ON THE COOLER HEATER UNIT. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200036 TERUMO TCM II COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP 4416

    Patients

    Seq Age Sex Outcome Treatment
    1