BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 3113168 · Received May 9, 2013

    Report

    Report Number
    1828100-2013-00444
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 18, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) CHECKED THE R1-R3 RESISTOR BANKS: R1 = 35 OHMS, R2 = 225 MEG OHMS, R3 = 50 OHMS. THE FSR ALSO NOTED THE UNIT WOULD PUMP IN ALL HEATING MODES AND THE COOL 3 AND COOL 4 SETTINGS, BUT THE UNIT WOULD NOT PUMP IN COOL #1 NOR COOL #2 SETTINGS. THE FSR ADVISED THE CUSTOMER THAT SPEED CONTROL RESISTORS R2 AND R3 NEED REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE COOLER HEATER UNIT WOULD NOT PUMP WATER IN THE "RECIRCULATION" MODE. 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 PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202716 DUAL COOLER/HEATER COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 11160

    Patients

    Seq Age Sex Outcome Treatment
    1