BEUDAMED
    FDA Adverse Event Death Summary report: N

    FEM-FLEX ADULT FEMORAL VENOUS CANNULA

    MDR report key: 901786 · Received August 20, 2007

    Report

    Report Number
    6000002-2007-05059
    Event Type
    Death
    Date Received
    August 20, 2007
    Date of Event
    August 3, 2007
    Report Date
    August 16, 2007
    Manufacturer
    EDWARDS LIFESCIENCE RESEARCH MEDICAL
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    C-BN-110 - BROKE DURING USE. IT WAS REPORTED THAT, WHEN THE CUSTOMER TOOK PT OFF ECMO, SHE/HE NOTICED A LEAK IN THE VENOUS CANNULA. FURTHER EXAMINATION REVEALED THAT THERE WAS A SLIT IN THE DEVICE. CUSTOMER CLAMPED AND REMOVED THE DEVICE. A FEW DAYS AFTER SURGERY, PT EXPIRED IN ICU. PT WAS ORIGINALLY ADMITTED TO THE HOSPITAL FOR ENDOCARDITIS FROM A MECHANICAL HEART VALVE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEM-FLEX ADULT FEMORAL VENOUS CANNULA CANNULA, CATHETER, AND TUBING DWF EDWARDS LIFESCIENCE RESEARCH MEDICAL DVFEM024 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR