BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER W/AMC THROMBOSHIELD

    MDR report key: 2183347 · Received July 28, 2011

    Report

    Report Number
    2015691-2011-15961
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    April 21, 2011
    Report Date
    June 30, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K812563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER WAS RECEIVED WITH THE CONTAMINATION SHIELD ATTACHED TO THE CATHETER. THE COMPLAINT OF "INACCURATE TEMPERATURE READINGS" WAS NOT CONFIRMED. THE THERMISTOR WAS SUBMERGED IN A 37.0C WATER BATH AND READ 37.2C ON VIGILANCE I MONITOR. THERMISTOR TEMPERATURE READING ACCURACY IS +/- .3C PER VIGILANCE OPERATOR¿S MANUAL. THERMISTOR CIRCUIT WAS CONTINUOUS. THERE WERE NO OPEN OR INTERMITTENT CONDITIONS. THERMISTOR CONNECTOR WAS OPENED WITH NO VISIBLE INCONSISTENCIES. THE BALLOON INFLATED CLEARLY AND CONCENTRICALLY AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. ALL THROUGH LUMENS WERE TESTED FOR PATENCY AND NO LEAKAGE OR OCCLUSION WAS OBSERVED. THERE WAS NO VISIBLE DAMAGE WAS OBSERVED FROM CATHETER BODY OR RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. VISUAL EXAMINATION WAS PERFORMED UNDER MICROSCOPE AT 10 X MAGNIFICATION. THE COMPLAINT COULD NOT BE CONFIRMED DURING THE ANALYSIS. THE CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED; IT IS NOT KNOWN WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET SPECIFICATION UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TEMPERATURE READINGS WERE OUT OF SPECIFICATION; HOWEVER, THE PATIENT'S TEMPERATURE WAS NORMAL. THE TEMPERATURE OF THE PATIENT WAS BEING MONITORED ORALLY. THE TEMPERATURE READING FROM THE CATHETER INDICATES 104; HOWEVER, THE ORAL TEMPERATURE OF THE PATIENT WAS 98.2. THERE WERE NO WARMING DEVICES BEING USED ON THE PATIENT. THE PATIENT DID NOT HAVE A FEVER. OTHER MEASUREMENTS SEEMED TO BE FINE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S TEMPERATURE IN THE OR WAS BEING MONITORED APPROXIMATELY 3 DIFFERENT WAYS AND THE DOCTORS USE THE ORAL READING OF THE TEMPERATURE. 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. NOT KNOWN WHAT OTHER THERAPIES WERE USED ON PATIENT. GE MARQUETTE MONITOR WAS USED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER W/AMC THROMBOSHIELD THERMODILUTION CATHETER DYG EDWARDS LIFESCIENCES, PR 831HF75 58971113

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR