BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER AND CANNULA

    MDR report key: 2915421 · Received January 9, 2013

    Report

    Report Number
    1828100-2012-01618
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 14, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWF
    PMA / PMN Number
    K890024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE WIRE ON THE CANNULA WAS BENT. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12340 CATHETER AND CANNULA DWF TERUMO CARDIOVASCULAR SYSTEMS CORP. 4951 0660668

    Patients

    Seq Age Sex Outcome Treatment
    1