BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO SOFT FLOW CANNULAE

    MDR report key: 1970053 · Received January 14, 2011

    Report

    Report Number
    1828100-2010-02892
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 14, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER OBSERVED A WIRE PROTRUDING AT THE DISTAL END OF THE CANNULAE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THE USER REPORTED SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES TO A PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO SOFT FLOW CANNULAE ARTERIAL CANNULAE DWF TERUMO CARDIOVASCULAR SYSTEMS CORP. 4882 0589210

    Patients

    Seq Age Sex Outcome Treatment
    1