BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-LINK DATA MANAGEMENT SYSTEM

    MDR report key: 2060881 · Received March 14, 2011

    Report

    Report Number
    1828100-2011-00583
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 14, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE SOFTWARE APPLICATION CLOSED DUE TO AN ERROR. THIS OCCURRED WHEN THE USER PRESSED THE START DATA BUTTON. THE DEVICE WAS USED FOR THE REMAINDER OF THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT 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 SYSTEMS CORP. 814851

    Patients

    Seq Age Sex Outcome Treatment
    1