BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER

    MDR report key: 11661106 · Received April 13, 2021

    Report

    Report Number
    2015691-2021-02437
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 26, 2021
    Report Date
    April 21, 2021
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K040287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 777F8 WITH A MONOJECT LIMITED VOLUME SYRINGE AND A NON-EDWARDS CONTAMINATIONS SHIELD WERE RETURNED FOR EXAMINATION. THE REPORTED EVENT OF CARDIAC OUTPUT AND SVO2 ISSUES WITH CATHETER WERE NOT CONFIRMED. NO FAULT MESSAGES SHOWED UP ON THE LAB VIGILANCE II MONITOR WHEN THE CATHETER WAS CONNECTED. THE THERMISTOR WAS FOUND TO READ 37.0 C WHEN SUBMERGED INTO A 37.0 C WATER BATH. THE CATHETER RAN CCO IN 37.0 C WATER BATH ON THE VIGILANCE II MONITOR FOR 5 MINUTES WITH NO ERROR. THE THERMISTOR AND THERMAL FILAMENT CIRCUITS WERE CONTINUOUS, THERE WERE NO OPEN OR INTERMITTENT CONDITIONS. NO VISIBLE INCONSISTENCIES WERE OBSERVED ON THE EEPROM DATA. BOTH THE THERMISTOR AND THERMAL FILAMENT CONNECTORS WERE OPENED AND FOUND NO VISIBLE INCONSISTENCIES. RESISTANCE VALUE OF THERMAL FILAMENT CIRCUIT WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE CATHETER PASSED IN-VITRO CALIBRATION AND ATTENUATION TEST. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THE BALLOON INFLATED CLEAR, CONCENTRIC AND REMAINED INFLATED FOR MORE THAN 5 MINUTES WITHOUT LEAKAGE. NO VISIBLE DAMAGE WAS OBSERVED FROM THE CATHETER BODY OR RETURNED SYRINGE. THE REPORTED EVENT COULD NOT BE CONFIRMED OR REPLICATED DURING THE ANALYSIS, AS THE DEVICE RESPONDED APPROPRIATELY DURING FUNCTIONAL TESTING. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE. INVASIVE PROCEDURES INVOLVE SOME PATIENT RISKS. ALTHOUGH SERIOUS COMPLICATIONS ARE RELATIVELY UNCOMMON, THE PHYSICIAN IS ADVISED, BEFORE DECIDING TO INSERT OR USE THE CATHETER, TO CONSIDER THE POTENTIAL BENEFITS IN RELATION TO THE POSSIBLE COMPLICATIONS. THE TECHNIQUES FOR INSERTION, METHODS OF USING THE CATHETER TO OBTAIN PATIENT DATA INFORMATION, AND THE OCCURRENCE OF COMPLICATIONS ARE WELL DESCRIBED IN THE LITERATURE. WITH ANY HEMODYNAMIC MONITORING, PRESSURE READINGS CAN CHANGE QUICKLY AND DRAMATICALLY. PRESSURE TUBING THAT IS USED WITH SWAN GANZ CATHETERS CAN ALSO BE A CONTRIBUTING FACTOR TO INACCURATE VALUES. IN REGARDS TO THE PRESSURE TUBING USED WITH SWAN GANZ CATHETERS, IT SHOULD BE NOTED THAT POOR DYNAMIC RESPONSE CAN BE CAUSED BY AIR BUBBLES, CLOTTING, EXCESSIVE LENGTHS OF TUBING, EXCESSIVELY COMPLIANT PRESSURE TUBING, SMALL BORE TUBING, LOOSE CONNECTIONS, OR LEAKS. PRESSURE READINGS SHOULD CORRELATE WITH THE PATIENTS CLINICAL MANIFESTATIONS. IT SHOULD BE NOTED THAT IN THIS CASE THERE WERE NO PATIENT COMPLICATIONS. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT NOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WITH THE EVALUATION RESULTS WHEN RECEIVED. LOT NUMBER WAS NOT PROVIDED, THEREFORE REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NUMBERS DID NOT MATCH THE MALE PATIENT'S CURRENT STATE. THE CARDIAC INDEX WAS 1.1 AND THE SVOS WAS IN THE HIGHS 40'S. A FLOTRAC THAT WAS ALREADY BEING USED IN THE IN THE ARTERIAL LINE WAS USED TO COMPLETE THE THERAPY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558803 SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER CATHETER, OXIMETER, FIBER-OPTI DQE EDWARDS LIFESCIENCES, PR 777F8

    Patients

    Seq Age Sex Outcome Treatment
    1