BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCO V CCO/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 3061464 · Received April 16, 2013

    Report

    Report Number
    2015691-2013-19825
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 21, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K040287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WITH MONOJECT 1.5CC LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. AN ARROW CONTAMINATION SHIELD AND INTRODUCER WERE SEATED ON THE CATHETER FROM 50CM TO 100CM. THE CONTAMINATION SHIELD WAS REMOVED FROM THE CATHETER FOR EVALUATION. THE THERMISTOR WAS SUBMERGED IN A 37.0C WATER BATH AND READ 37.1C. THE CATHETER RAN CCO IN 37.0 C WATER BATH ON VIGILANCE I AND VIGILANCE II MONITORS FOR 5 MINUTES WITH NO ERROR MESSAGE. THERMISTOR AND THERMAL FILAMENT CIRCUITS WERE CONTINUOUS, THERE WERE NO OPEN OR INTERMITTENT CONDITIONS. NO VISIBLE INCONSISTENCIES WERE OBSERVED ON EEPROM DATA. RESISTANCE VALUE OF THE THERMAL FILAMENT CIRCUIT MEASURED WITHIN SPECIFICATIONS AT 39.35 OHMS. BOTH THERMISTOR AND THERMAL FILAMENT CONNECTORS WERE OPENED AND NO VISIBLE INCONSISTENCIES WERE FOUND. 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 TO THE CATHETER BODY OR RETURNED SYRINGE WAS OBSERVED. BALLOON INFLATION TEST WAS PERFORMED USING RETURNED SYRINGE WITH 1.5CC AIR. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION AND WITH THE UNAIDED EYES. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. THE COMPLAINT OF ABNORMAL CCO READINGS COULD NOT BE CONFIRMED DURING THE EVALUATION. NO INDICATION OF A MANUFACTURING DEFECT WAS NOTED DURING THE ANALYSIS. IT COULD NOT BE DETERMINED IF ANY CLINICAL OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "CCO READING WAS ABNORMALLY HIGH ON THE FIRST DAY OF USE. THE CCO READING WAS 10L WHERE THE BOLUS CO READING WAS ONLY 3L. THE CUSTOMER COMMENTED THAT SINCE THE PATIENT WAS ON INTRA-AORTIC BALLOON PUMP (IABP), THE CCO READING WAS EXPECTED TO BE LESS THAN 3L." THERE WERE NO ERROR MESSAGES SHOWN ON THE MONITOR OR NO ABNORMALITIES NOTED IN THE CATHETER. THE SAMPLE OF TRACING WAS NOT AVAILABLE. THE MONITOR AND THE SYSTEM WERE REPLACED, BUT THE PROBLEM WAS NOT SOLVED. THE CATHETER WAS PULLED BACK TO CORRECT THE POSITION, BUT THE PROBLEM WAS NOT SOLVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163912 SWAN-GANZ CCO V CCO/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD SWAN-GANZ THERMODILUTION CATHETER DQE EDWARDS LIFESCIENCES, PR 177HF75J

    Patients

    Seq Age Sex Outcome Treatment
    1