BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2001912 · Received February 27, 2011

    Report

    Report Number
    2015691-2011-14924
    Event Type
    Malfunction
    Date Received
    February 27, 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 CATHETER WAS RETURNED OUT OF TRAY WITH AN ARROW CONTAMINATION SHIELD AND ONE 2 GANG EDWARDS MANIFOLD ATTACHED TO THE PROXIMAL INJECTATE HUB. THE CATHETER PASSED IN-VITRO CALIBRATION, ATTENUATION AND X-TALK TESTING. THE CATHETER BODY WAS FOUND TO HAVE AN INDENTATION 88CM PROXIMAL OF THE CATHETER TIP, AT THE SAME LOCATION AS THE PROXIMAL END OF THE ARROW CONTAMINATION SHIELD. THE THERMISTOR AND THERMAL FILAMENT WERE FOUND TO FUNCTION NORMALLY. THERE WERE NO OPEN OR INTERMITTENT CONDITIONS. THE THERMISTOR READS 37 DEGREES C WHEN SUBMERGED INTO A 37 DEGREES C WATER BATH. THE CATHETER WAS ABLE TO COLLECT CCO DATA FOR 5 MIN. WITHOUT AN ERROR MESSAGE ON BOTH THE VIGILANCE I AND II SYSTEMS. THE EEPROM CHECK SUM MATCHES THE COMPUTED CHECK SUM DATA. THE BALLOON INFLATED CLEAR AND CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. ALL THROUGH LUMENS WERE FOUND TO BE PATENT AND THEY DID NOT LEAK. BOTH THERMISTOR AND THERMAL FILAMENT HOUSINGS WERE OPENED AND THERE WERE NO ABNORMALITIES OBSERVED. NOTE THAT THE PRESSURE TRANSDUCER WAS NOT RETURNED WITH THE CATHETER. 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 COMPLETED.

    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