BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 3102524 · Received May 2, 2013

    Report

    Report Number
    1828100-2013-00400
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 1, 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 SERVICE REPRESENTATIVE (FSR) TROUBLESHOT THE REPORTED PROBLEM AND DISCOVERED POWER CORD CONNECTOR WAS FAULTY. THE POWER CORD WAS SUPPLIED BY ANOTHER MFR. THE USER FACILITY'S BIOMEDICAL ENGINEER WILL REPLACE POWER CORD.

    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 KEPT TURNING OFF. 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
    193210 DUAL COOLER/HEATER COOLING AND HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 11160

    Patients

    Seq Age Sex Outcome Treatment
    1