BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO TCM II COOLING AND HEATING SYSTEM

    MDR report key: 2081917 · Received April 5, 2011

    Report

    Report Number
    1828100-2011-00839
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 11, 2011
    Report Date
    April 5, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO STARTING CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER FOUND THAT THE PRIME SOLUTION COULD NOT BE WARMED TO THE PROTOCOL LEVEL OF 37 DEGREES CELSIUS. THIS DELAYED THE START OF THE PROCEDURE FOR 5 MINUTES. THE DECISION WAS MADE TO PROCEED WITH THE PROCEDURE; THE PRIME TEMPERATURE WAS ABOUT 35 DEGREES CELSIUS. THE CPB MODE WAS FUNCTIONAL AND THE CARDIOPLEGIA WAS COOLED IN THE NORMAL PRACTICE. ON RE-WARMING THE PATIENT THE WATER TEMPERATURE OF THE TCM II DID RISE BUT THE WATER FLOW RATE WAS VERY SLOW. THE PATIENT BLADDER TEMPERATURE WAS NOT WARMED TO NORMAL LEVELS, AND THE TEAM ELECTED TO WEAN THE PATIENT OFF CPB WITH A BLADDER TEMPERATURE OF 34.7 DEGREES CELSIUS. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS WITHOUT DIFFICULTY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO TCM II COOLING AND HEATING SYSTEM HEATING COOLING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention