BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2052375 · Received April 12, 2011

    Report

    Report Number
    2015691-2011-15214
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K934742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED WITH THE DATA FROM THE (B)(6) DATA LOGGERS. ANALYSIS OF THE DATA FOUND THAT DUE TO THE SIGNAL TO NOISE RATIO (SNR), IT TAKES MORE TIME (20+ MINUTES) FOR THE CCO VALUES TO AVERAGE. WHEN ICO IS PERFORMED SHORTLY AFTER START UP, THE CCO VALUES ARE INITIALLY LOW. IF THE USER REACTS TO THIS INITIAL VALUE AND DISREGARDS CCO FOR THE DURATION OF THE CASE, THEY WILL NOT SEE THAT IT TRENDS UP TO AN EXPECTED VALUE AFTER AVERAGING. THE INVESTIGATION RESULTS WERE SHARED WITH THE CUSTOMER DURING AN ON-SITE VISIT.

    Additional Manufacturer Narrative · 1

    ONE SWAN-GANZ CATHETER WAS RECEIVED WITH THE CONTAMINATION SHIELD ATTACHED TO THE CATHETER; THE PROXIMAL END WAS APPROXIMATELY 105CM FROM THE TIP. THE CATHETER RAN CCO ON BOTH VIGILANCE I AND VIGILANCE II MONITORS FOR 5 MINUTES WITH NO ERROR MESSAGES. THERE WAS NO VISIBLE INCONSISTENCIES OBSERVED ON EEPROM DATA. THERMISTOR AND THERMAL FILAMENT CIRCUIT WERE CONTINUOUS. THE THERMISTOR WAS FOUND TO READ 37.2 C WHEN SUBMERGED IN A 37.1 C WATER BATH, WHICH IS WITHIN ALLOWABLE SPECIFICATION. THERMISTOR RESISTANCE WHEN SUBMERGED IN A 37.1C WATER BATH READ 148350 OHMS, WHICH IS WITHIN THE ALLOWABLE SPECIFICATION. THERE WERE NO OPEN OR INTERMITTENT CONDITIONS. BOTH THERMISTOR AND THERMAL FILAMENT CONNECTORS WERE OPENED WITH NO VISIBLE INCONSISTENCIES. ALL THROUGH LUMENS WERE PATENT WITHOUT LEAKAGE OR OCCLUSION. BALLOON INFLATED CLEAR, CONCENTRIC AND REMAINED INFLATED FOR MORE THAN 5 MINUTES. THERE WAS NO VISIBLE DAMAGE OBSERVED ON RETURNED THE MONOJECT 1.5CC LIMITED VOLUME SYRINGE. VISUAL EXAMINATION WAS PERFORMED UNDER 10 X MAGNIFICATIONS. TEMPERATURE READINGS WERE DONE ON VIGILANCE I AND II MONITORS. RESISTANCE TESTING WAS MEASURED USING FLUKE MULTIMETER . THE BALLOON INFLATION WAS PERFORMED WITH AIR USING THE RETURNED SYRINGE FOR 5 MINUTES. LUMEN PATENCY AND LEAKAGE WAS PERFORMED AS FOLLOWS: A 10CC SYRINGE WAS CONNECTED TO EACH OF THE LUMENS BEING TESTED. EACH ASSOCIATED PORT WAS COVERED WITH A FINGERTIP; ENTIRE CATHETER WAS IMMERSED IN WATER AND PRESSURIZED WITH AIR BY COMPRESSING THE SYRINGE PLUNGER. ANY LEAKAGE (BUBBLES EXITING) FROM THE CATHETER BODY OR FROM ANY CONNECTOR WAS VISUALLY EXAMINED. ALL THROUGH LUMENS WERE PATENT WITHOUT LEAKAGE OR OCCLUSION. THE CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED; IT IS UNKNOWN WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STAFF HAS BEEN OBTAINING WIDELY VARYING CO/CI VALUES THAT DO NOT MATCH THE PATIENT'S CLINICAL STATUS. IT HAS BEEN INDICATED THAT THE STAFF ARE NOT TO USE THE CCO FEATURE AND TO OBTAIN ANY BOLUS CO VALUES OR USE THE FLOTRAC DEVICE. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD CONTINOUS CARDIAC OUPTUT CATHETER DYG EDWARDS LIFESCIENCES, PR 746HF8

    Patients

    Seq Age Sex Outcome Treatment
    1