BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP OXIMETRY TD CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 3051160 · Received April 10, 2013

    Report

    Report Number
    2015691-2013-19782
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K926450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION REVEALED THAT THERMISTOR WAS READ 37.1 C WHEN SUBMERGED INTO A 37.1 C WATER BATH. AS PER IFU, THERMISTOR TEMPERATURE READING ACCURACY IS +/- 0.3C PER VIGILANCE MANUAL. THE THERMISTOR CIRCUIT WAS CONTINUOUS, AND THERE WERE NO OPEN OR INTERMITTENT CONDITIONS. THE THERMISTOR CONNECTOR WAS OPENED AND NO VISIBLE INCONSISTENCIES WERE FOUND. UPON REMOVAL OF THE CONTAMINATION SHIELD, A SLIGHT KINK WAS FOUND IN THE 92CM AREA. DAMAGE TO THE CATHETER BODY MAY AFFECT THE ACCURACY OF PRESSURE BEING MONITORED. PER SWAN GANZ IFU, "OVERTIGHTENING THE TUOHY-BORST ADAPTERS OF THE CONTAMINATION SHIELD MAY IMPAIR CATHETER FUNCTION." THE BALLOON INFLATED CLEARLY AND CONCENTRICALLY AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THERE WAS NO VISIBLE DAMAGE WAS OBSERVED FROM RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. LOT NUMBER WAS NOT PROVIDED, THEREFORE REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. THE COMPLAINT OF CO DIFFICULTY COULD NOT BE CONFIRMED DURING THE EVALUATION. THE MEASUREMENTS BETWEEN A SWAN-GANZ CATHETER AND THE FLOTRAC HAVE DIFFERENT PARAMETERS AND THE SAME MEASUREMENTS WILL NOT BE OBSERVED. NO DEFECTS WERE NOTED ON THE CATHETER. VARIOUS FACTORS CAN INFLUENCE THE ACCURACY AND REPRODUCIBILITY OF BOLUS THERMODILUTION CARDIAC OUTPUT VALUES, INCLUDING INACCURATE INJECTATE TEMPERATURE OR VOLUME, INCONSISTENT TIMING OF INJECTATE, INACCURATE COMPUTATION CONSTANTS, RESPIRATORY CYCLE INFLUENCES, AND THERMAL INSTABILITY POST CARDIO-PULMONARY BYPASS. IN THIS CASE, MINIMAL CLINICAL INFORMATION WAS RECEIVED SO THE MOST LIKELY CAUSE CANNOT BE DETERMINED WITH ANY CERTAINTY. IT IS POSSIBLE THAT CLINICAL FACTORS CONTRIBUTED TO THE EVENT REPORTED. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT END-USER WAS SHOOTING BOLUS CO AND IT DID NOT CORRELATE WITH THE VALUE OF THE FLOTRAC WITH THE VIGILEO MONITOR. IT WAS INDICATED THAT THE SALES REP. EXPLAINED THE DIFFERENCES WITH THE MEASUREMENTS; HOWEVER, THE CUSTOMER FELT THAT THE CATHETER HAD AN ISSUE. THE STAFF WAS OBSERVING THE FLOTRAC/VIGILEO MEASUREMENTS. THE ACTUAL VALUES WERE NOT REPORTED, NOR WAS THE AMOUNT OF THE PERCEIVED INACCURACY. IT WAS ONLY REPORTED THAT THE SWAN-GANZ CATHETER AND FLOTRAC MEASUREMENTS WERE NO CORRELATING. THERE WERE NO PATIENT COMPLICATIONS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152592 SWAN-GANZ VIP OXIMETRY TD CATHETER WITH AMC THROMBOSHIELD CATHETER, OXIMETER, FIBEROPTIC DQE EDWARDS LIFESCIENCES, PR 782HF75

    Patients

    Seq Age Sex Outcome Treatment
    1