BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2171900 · Received July 22, 2011

    Report

    Report Number
    2015691-2011-15903
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K934742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RECEIVED WITH THE CONTAMINATION SHIELD ATTACHED TO THE CATHETER, THE PROXIMAL END WAS APPROXIMATELY 90CM FROM THE TIP. THE CAL-CUP WAS NOT RETURNED, TESTING WAS DONE USING A LAB CAL-CUP. THE CATHETER PASSED IN-VITRO CALIBRATION ON BOTH VIGILANCE I AND II MONITORS. THE CATHETER ALSO PASSED TRANSMISSION AND CROSS-TALK TESTING. WHEN THE CATHETER WAS CONNECTED TO BOTH VIGILANCE I AND II MONITORS, THE ERROR MESSAGE, "FAULT: CHECK THERMISTOR CONNECTION" WAS RECEIVED. THE THERMISTOR CONNECTOR WAS OPENED AND BOTH LEAD-WIRES WERE FOUND BROKEN FROM THE POSTS. THIS DEFECT IS A CONFIRMED MANUFACTURING DEFECT. NO VISIBLE INCONSISTENCIES WERE OBSERVED ON EEPROM DATA. THE THERMAL FILAMENT CIRCUIT WAS CONTINUOUS. THERMAL FILAMENT CONNECTOR WAS OPENED WITH NO VISIBLE INCONSISTENCIES. THE BALLOON INFLATED CLEARLY AND CONCENTRICALLY AND REMAINED INFLATED FOR 5 MINUTES. WITHOUT LEAKAGE. A 10CC SYRINGE WAS CONNECTED TO EACH OF THE LUMENS BEING TESTED. EACH ASSOCIATED PORT WAS COVERED WITH A FINGERTIP AND THE ENTIRE CATHETER WAS IMMERSED IN WATER AND PRESSURIZED WITH AIR BY COMPRESSING THE SYRINGE PLUNGER. NO LEAKAGE OR OCCLUSION WAS FOUND. NO VISIBLE DAMAGE WAS OBSERVED ON THE OPTICAL MODULE CONNECTOR, CATHETER BODY, OR RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. LEAD WIRE DAMAGE WAS CONFIRMED ON THE RETURNED DEVICE; AN AWARENESS TRAINING WILL BE CONDUCTED. 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 THERE WAS NO DIRECT INFORMATION PROVIDED BY THE NURSE TO CLINICAL ENGINEERING. IT WAS NOTED THE PHYSICIAN QUESTIONED THE ACCURACY OF THE CCO AND SVO2 MEASUREMENTS. ENGINEERING WAS UNABLE TO PROVIDE DIRECT TROUBLESHOOTING SUPPORT.

    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