BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HX2 TEMPERATURE MANAGEMENT SYSTEM

    MDR report key: 2884790 · Received December 3, 2012

    Report

    Report Number
    1828100-2012-01513
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K071521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS, BUT NOT YET COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE UNIT HAD AN OVER TEMPERATURE ISSUE. 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
    1 HX2 TEMPERATURE MANAGEMENT SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 809810

    Patients

    Seq Age Sex Outcome Treatment
    1