BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCO

    MDR report key: 2133327 · Received June 13, 2011

    Report

    Report Number
    2133327
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 12, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SWAN GANZ CCO/VIP WAS PLACED THROUGH THE CORDIS INTRODUCER. WHEN THE PULMONARY ARTERY LINE WAS FLUSHED, FLUID CAME OUT OF THE CENTRAL VENOUS PRESSURE PORT ON THE CATHETER. WHEN THE CENTRAL VENOUS PRESSURE LINE WAS FLUSHED, FLUID CAME OUT OF THE PULMONARY ARTERY PORT ON THE CATHETER. THE ANESTHESIOLOGIST REMOVED THE LINE AND PLACED A NEW ONE THAT FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CCO CATHETER DYG EDWARDS LIFESCIENCES 139HF75P *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR