BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMODILUTION VENOUS INFUSION PORT (VIP) FIVE LUMEN

    MDR report key: 2192969 · Received July 5, 2011

    Report

    Report Number
    2192969
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    May 24, 2011
    Report Date
    July 5, 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

    CHECKED THE PULMONARY ARTERY (PA) CATHETER TEMPERATURE AND IT READ 104.5. TOOK THE TEMPERATURE AXILLARY, TEMPANIC, TEMPORAL AND THE READINGS WERE 102.4. CALLED BIOMED TO CHECK OUT THE MONITOR AND THE CABLES. THEY FOUND NOTHING WRONG WITH THE CABLES. THE CABLES AND MODULES WERE REPLACED WITH NO CHANGE NOTED.====================== MANUFACTURER RESPONSE FOR THERMODILUTION VENOUS INFUSION PORT (VIP), SWAN GANZ (PER SITE REPORTER)======================THEY ARE SENDING RETURN PACKAGING SO THE DEVICE CAN BE RETURNED TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMODILUTION VENOUS INFUSION PORT (VIP) FIVE LUMEN CATHETER, FLOW DIRECTED, SWAN GANZ DYG EDWARDS LIFESCIENCES, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR NONE KNOWN.