BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC PERFUSION CANNULA

    MDR report key: 904012 · Received August 29, 2007

    Report

    Report Number
    6000002-2007-50700
    Event Type
    Malfunction
    Date Received
    August 29, 2007
    Report Date
    August 14, 2007
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER CANNULATION, THE SURGEON IDENTIFIED A HOLE BETWEEN THE CANNULA TIP AND THE FLEXIBLE BODY. BLOOD LEAKAGE CAUSED RECANNULATION. THE SAME EVENT HAPPENED TO 4 OTHER DEVICES OF THE SAME MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AORTIC PERFUSION CANNULA PERFUSION CANNULA DWF EDWARDS LIFESCIENCES RESEARCH MEDICAL ARH241190TA 58164188

    Patients

    Seq Age Sex Outcome Treatment
    1 YR