BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS INFUSION PORT (VIP) FIVE LUMEN

    MDR report key: 2182091 · Received July 2, 2011

    Report

    Report Number
    2182091
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    May 10, 2011
    Report Date
    July 2, 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 ICU NURSE WAS CHECKING THE PATIENT'S TEMPERATURE. THE READING FROM THE SWAN GANZ PA CATHETER WAS READING 101 DEGREES. WHEN THE TEMPERATURE WAS TAKEN BY TYMPANIC, TEMPORAL, AND ORALLY, THEY REGISTERED 97.6 DEGREES. THE NURSE CHANGED THE CABLES AND MODULES. CALLED BIOMED AND THEY CHECKED ALL CABLES AND MODULES USED ON THE PATIENT. THEY WERE ALL FOUND TO BE WORKING CORRECTLY.======================MANUFACTURER RESPONSE FOR THERMODILUTION VENOUS INFUSION PORT (VIP) SWAN GANZ, SWAN GANZ (PER SITE REPORTER)======================THEY ARE SENDING A RETURN BOX 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, FLOW DIRECTED, SWAN GANZ THERMODILUTION DYG EDWARDS LIFESCIENCES, LLC. 831HF75 *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR NONE KNOWN.