BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HX2 TEMPERATURE MANAGEMENT SYSTEM

    MDR report key: 2022991 · Received February 24, 2011

    Report

    Report Number
    1828100-2011-00407
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 24, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K071521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THERE WAS A PROBLEM WITH THE UNIT. THE BIOMED AT THE SITE CHECKED THE DEVICE AND SAW THAT THE LIGHT WITH THE WRENCH WAS ON. WHEN ATTEMPTING TO CHECK IT OUT, A GRINDING NOISE WAS HEARD AND THE "EOA" MESSAGE APPEARED ON THE "B" SIDE. THE DEVICE WAS USED FOR THE REMAINDER OF THE SURGICAL PROCEDURE. THE USER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF 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