BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2172033 · Received July 22, 2011

    Report

    Report Number
    2015691-2011-15907
    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 AT THE PROXIMAL END APPROXIMATELY 94CM 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. THE 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. THE THERMISTOR AND THERMAL FILAMENT CIRCUIT WERE CONTINUOUS. THE READ 37.1 C WHEN SUBMERGED IN A 37.0 C WATER BATH. THERE WERE NO OPEN OR INTERMITTENT CONDITIONS. BOTH THERMISTOR AND THERMAL FILAMENT CONNECTORS WERE OPENED WITH NO VISIBLE INCONSISTENCIES. THE SYRINGE WAS NOT RETURNED, TESTING WAS DONE USING LAB SYRINGE. THE BALLOON INFLATED CLEAR AND CONCENTRIC 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; ENTIRE CATHETER WAS IMMERSED IN WATER AND PRESSURIZED WITH AIR BY COMPRESSING THE SYRINGE PLUNGER. ALL THROUGH LUMENS WERE PATENT WITHOUT LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE WAS OBSERVED ON THE OPTICAL MODULE CONNECTOR OR CATHETER BODY. VISUAL EXAMINATION WAS PERFORMED UNDER 10 X MAGNIFICATIONS. THE COMPLAINT COULD NOT BE CONFIRMED DURING TESTING; NO PRODUCT PROBLEMS WERE IDENTIFIED. IT IS NOT KNOWN IF SOME PROCEDURAL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC INDEX (CI) AND CARDIAC OUTPUT (CO) WOULD DROP TO ZERO. IT WAS FURTHER INDICATED THAT THE INCORRECT SVO2 MEASUREMENTS ALSO PROMPTED NUMEROUS RECALIBRATIONS BY THE NURSE. ALL CABLES AND CCO BOXES WERE EXCHANGED WITH KNOWN GOOD EQUIPMENT. ENGINEERING DID NOT 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