BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HX2 TEMPERATURE MANAGEMENT SYSTEM

    MDR report key: 1842295 · Received August 27, 2010

    Report

    Report Number
    1828100-2010-01181
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 27, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K071521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER OBSERVED AN E08 ERROR CODE MESSAGE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED AFTER A CARDIOPULMONARY BYPASS PROCEDURE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HX2 TEMPERATURE MANAGEMENT SYSTEM COOLING & HEATING SYSTEM DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 809810

    Patients

    Seq Age Sex Outcome Treatment
    1