BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-LINK DATA MANAGEMENT SYSTEM

    MDR report key: 2102480 · Received May 20, 2011

    Report

    Report Number
    1828100-2011-01435
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 20, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT SWITCHING FROM THE TABLE TO THE GRAFT MODE, THEY LOST AN ACCURATE DISPLAY OF THE ART BLOOD FLOW. THE DEVICE WAS NOT CHANGED OUT. THE CASE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-LINK DATA MANAGEMENT SYSTEM PERFUSION LIBRARY SOFTWARE DWA TERUMO CARDIOVASCULAR SYSTEM CORP. 814850

    Patients

    Seq Age Sex Outcome Treatment
    1