BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2001899 · Received February 25, 2011

    Report

    Report Number
    2015691-2011-14921
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 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

    ONE SWAN-GANZ, MODEL NO. 746HF8 WAS RECEIVED WITH A CONTAMINATION SHIELD WAS ATTACHED TO CATHETER. UPON REMOVAL OF THE CONTAMINATION SHIELD, THE CATHETER BODY WAS FOUND KINKED AT TWO DIFFERENT LOCATIONS, APPROXIMATELY 49CM AND 81CM PROXIMAL FROM THE TIP. THE CATHETER ALSO APPEARED COILED IN DIFFERENT DIRECTIONS. THE REPORTED DEFECT OF "THERMISTOR PROBLEM" WAS NOT CONFIRMED. CATHETER RAN CCO ON VIGILANCE I AND VIGILANCE II MONITORS FOR 5 MINUTES WITH NO ERROR MESSAGES. NO VISIBLE INCONSISTENCIES WERE OBSERVED ON EEPROM DATA. THERMISTOR AND THERMAL FILAMENT CIRCUIT WERE CONTINUOUS. THE THERMISTOR WAS FOUND TO READ 37.2 TO 37.3 C WHEN SUBMERGED IN A 37.1 C WATER BATH, WHICH IS WITHIN THE ALLOWABLE SPECIFICATION. THERMISTOR RESISTANCE WHEN SUBMERGED IN A 37.1C WATER BATH READ 13399 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 OTHER THROUGH LUMENS WERE PATENT WITHOUT LEAKAGE OR OCCLUSION. BALLOON INFLATED CLEARLY AND CONCENTRICALLY AND REMAINED INFLATED FOR MORE THAN 5 MINUTES. VISUAL EXAMINATION WAS PERFORMED UNDER 10 X MAGNIFICATIONS. TEMPERATURE READINGS WERE DONE ON VIGILANCE I MONITOR. RESISTANCE TESTING WAS MEASURED USING FLUKE MULTIMETER. 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. NO LEAKAGE WAS INDENTIFIED. ALL THROUGH LUMENS WERE PATENT WITHOUT LEAKAGE OR OCCLUSION. 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. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STAFF IS OBTAINING WIDELY VARYING CO/CI VALUES THAT DO NOT MATCH THE PATIENT'S CLINICAL STATUS. THERE HAS BEEN NO ERROR MESSAGES OBSERVED. EXTENSIVE FOLLOW UP WITH THE STAFF WAS CONDUCTED IN AN ATTEMPT TO DETERMINE POTENTIAL CAUSES (E.G. A LARGE RATE OF BOLUS' BEING PERFORMED, THERMISTOR PROBLEM). THEY WERE ADVISED TO WATCH THE START SCREEN (SOMETIMES VALUES WOULD DISAPPEAR ON AND OFF SCREEN), TROUBLESHOOTING WAS PERFORMED. THE STAFF WAS INSTRUCTED BY THE CLINICAL NURSE SPECIALIST NOT TO USE THE CCO FEATURE AT THIS TIME. THERE WERE 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 THERMODILUATION COMBO CONTINUOUS CARDIAC OUTPUT CATHETER DYG EDWARDS LIFESCIENCES, PR 746HF8

    Patients

    Seq Age Sex Outcome Treatment
    1