BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTERIAL CANNULA

    MDR report key: 1062609 · Received June 18, 2008

    Report

    Report Number
    6000002-2008-07627
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PRODUCT DESIGN COMPLAINT: IT WAS REPORTED THAT BECAUSE THERE ARE NO DEPTH MARKINGS ON THE ARTERIAL CANNULA, THE SURGEON HAD TO PULL OUT THE CANNULA RESULTING IN THE PT LOSING 2L OF BLOOD. AS A RESULT CONVERTED FROM MIS TO FULL STERNOTOMY. PT WAS IN GOOD CONDITION POST SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CANNULA ARTERIAL CANNULA DWF EDWARDS LIFESCIENCES ER23 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other