BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC PERFUSION CANNULA

    MDR report key: 923917 · Received October 2, 2007

    Report

    Report Number
    6000002-2007-05208
    Event Type
    Malfunction
    Date Received
    October 2, 2007
    Date of Event
    September 18, 2007
    Report Date
    September 18, 2007
    Manufacturer
    EDWARDS LIFESCIENCES, RESEARCH MEDICAL
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON CUT OFF THE END OF THE CANNULA AND USED IT. HE/SHE DID NOT WANT TO COMPROMISE AORTA BY REPLACING THE CANNULA. THE WHITE CAP WAS PLACED OVER THE CANNULA TIP. BUT ONCE THE SURGEON TRIED TO REMOVE THE CAP, IT WAS TEARING AND SEPARATING, LEAVING A PIECE IN THE CANNULA. IN A PHONE CALL LATER WITH THE PERFUSIONIST, IT WAS CLARIFIED THAT THE CAP BROKE FROM THE CANNULA. THE SURGEON CUT OFF THE END WHERE THE CANNULA BROKE OFF TO PREVENT PIECES FROM REACHING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AORTIC PERFUSION CANNULA CANNULA DWF EDWARDS LIFESCIENCES, RESEARCH MEDICAL ARS022S 58294664

    Patients

    Seq Age Sex Outcome Treatment
    1 YR