BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO SOFT FLOW CANNULAE

    MDR report key: 1880388 · Received October 15, 2010

    Report

    Report Number
    1828100-2010-01743
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 15, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWF
    PMA / PMN Number
    K890024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE END OF THE CANNULA WAS CRUSHED ABOUT TWO INCHES. THE USER ALSO REPORTED THE WIRE REINFORCEMENT WAS CRUSHED. AS A RESULT, AN ALTERNATE DEVICE WAS USED FOR THE PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE 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. 4949 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1