BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS INFUSION PORT (VIP) FIVE LUMEN

    MDR report key: 2182052 · Received July 2, 2011

    Report

    Report Number
    2182052
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 9, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, LLC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S SWAN GANZ WAS ATTACHED TO THE GE MARQUETTE MONITOR. THE TEMPERATURE READING WAS 104.0 DEGREES. WHEN THE TEMPERATURE WAS TAKEN TEMPORALLY, IT REGISTERED AT 98.2 DEGREES. ALL CABLES WERE CHANGED AND THE MODULE. THIS DID NOT CHANGE THE RESULTS. THE PATIENT WAS AFEBRILE. BIOMED WAS CALLED IN AND THE MONITOR WAS CHECKED AS WELL AS MODULES AND ALL CABLES INVOLVED. EQUIPMENT AND CABLES WERE FOUND TO BE IN WORKING ORDER.======================MANUFACTURER RESPONSE FOR THERMODILUTION VENOUS INFUSION PORT (VIP)SWAN GANZ, SWAN GANZ (PER SITE REPORTER)======================EDWARDS LIFESCIENCES IS SENDING RETURN BOX TO HOSPITAL TO HAVE PRODUCT RETURNED TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS INFUSION PORT (VIP) FIVE LUMEN CATHETER, SWAN GANZ DYG EDWARDS LIFESCIENCES, LLC. 831HF75 58971113

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR