BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 3102620 · Received May 1, 2013

    Report

    Report Number
    1828100-2013-00410
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SVC REP (FSR) WAS ABLE TO DUPLICATE PROBLEM REPORTED. THE FSR WILL ORDER A 38/42 THERMOSTAT ASSEMBLY AND REPLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE COOLER HEATER "38 DEGREE CELSIUS" MODE WAS NOT WORKING. WHEN THE OPERATOR SETS THE MODE TEMP TO 38 DEGREES, THE COOLER HEATER WOULD NOT STOP AT +/- DEGREE AS IT SHOULD. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190675 DUAL COOLER/HEATER COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 11160

    Patients

    Seq Age Sex Outcome Treatment
    1