BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 2922407 · Received January 14, 2013

    Report

    Report Number
    1828100-2013-00006
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONFIRMED BY THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED). THE BIOMED ORDERED A REPLACEMENT AND WILL DO THE INSTALLATION. IF ADDITIONAL INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONFIRMED BY THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED). THE BIOMED ORDERED A REPLACEMENT AND WILL DO THE INSTALLATION. IF ADDITIONAL INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE COOLER/HEATER THERMOMETER WAS READING FOUR DEGREES CELSIUS ABOVE THE SELECTED TEMP AND TWO DEGREES CELSIUS ABOVE THE ACTUAL WATER TEMP. THE DEVICE WAS NOT CHANGED OUT, AS THEY CONTINUED TO USE FOR THIS CASE. AFTER THE CASE WAS COMPLETED, THEY CHANGED OUT THE UNIT. 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
    20602 DUAL COOLER/HEATER COOLING & HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 11160

    Patients

    Seq Age Sex Outcome Treatment
    1