BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2183380 · Received July 28, 2011

    Report

    Report Number
    2015691-2011-15966
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    May 18, 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. UPON REMOVAL OF THE CONTAMINATION SHIELD, A KINK WAS FOUND APPROXIMATELY 49CM FROM THE TIP. THE COMPLAINT OF "INACCURATE TEMPERATURE READINGS" WAS NOT CONFIRMED. THE THERMISTOR WAS SUBMERGED IN A 37.0C WATER BATH AND READ 37.1C ON VIGILANCE I MONITOR. THERMISTOR TEMPERATURE READING ACCURACY IS +/- .3C PER VIGILANCE OPERATORS 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 THERE WAS LEAKAGE OR OCCLUSION OBSERVED. NO VISIBLE DAMAGE WAS OBSERVED RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. VISUAL EXAMINATION WAS PERFORMED UNDER MICROSCOPE AT 10X 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. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP WITH CUSTOMER INDICATED THAT THIS WAS THE CORRECT COMPLAINT FOR THE MEDWATCH THAT WAS SUBMITTED; HOWEVER, THE OCCURRENCE DATE WAS INCORRECTLY REPORTED INITIALLY.

    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 IS BEING MONITORED ORALLY. EXACT TEMPERATURE READINGS OF THE PATIENT WERE NOT REPORTED. 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. TROUBLESHOOTING WAS PERFORMED WITHOUT SUCCESS. CUSTOMER IS USING GE MARQUETTE MONITOR.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1