BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3050062 · Received April 10, 2013

    Report

    Report Number
    2015691-2013-19781
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 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. NO INTRODUCER OR CONTAMINATION SHIELD WERE RETURNED WITH THE CATHETER. THE THERMISTOR READ 34.0 C WHEN SUBMERGED INTO A 37.0 C WATER BATH. THE THERMISTOR AND THERMAL FILAMENT CIRCUIT WERE CONTINUOUS WITH NO OPEN OR INTERMITTENT CONDITIONS. BOTH THE THERMISTOR AND THERMAL FILAMENT CONNECTORS WERE OPENED AND NO VISIBLE INCONSISTENCIES WERE FOUND. CONTINUITY TESTING TO THE THERMISTOR RESISTOR REVEALED THAT THE RESISTANCE VALUE WAS NOT WITHIN THE ALLOWABLE SPECIFICATION. CONTINUITY TESTING OF THE THERMISTOR CIRCUIT WAS FOUND WITHIN THE ALLOWABLE SPECIFICATION. NO VISIBLE INCONSISTENCIES WERE OBSERVED ON EEPROM DATA. 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. 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 CUSTOMER REPORT OF ABNORMAL MEASUREMENT WAS CONFIRMED DURING THE EVALUATION. THE DEFECT WAS CONFIRMED TO BE RELATED TO THE MANUFACTURING PROCESS. AN INVESTIGATION HAS BEEN INITIATED TO DETERMINE THE ROOT CAUSE AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLOOD TEMPERATURE READING WAS INDICATED AT 35 DEGREES C BUT THE RECTAL TEMPERATURE AT THE TIME WAS 38 DEGREES C, DURING USE. THE CUSTOMER COMMENTED THAT 3 DEGREES C TEMPERATURE DIFFERENCE IS TOO BIG. NO ERROR MESSAGES WERE OBSERVED AND IT WAS ABLE TO MEASURE CONTINUOUS CARDIAC OUTPUT (CCO). NO PROBLEM ON THE CATHETER BODY WERE NOTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153385 SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD SWAN-GANZ THERMODILUTION CATHETER DQE EDWARDS LIFESCIENCES, PR 774HF75J

    Patients

    Seq Age Sex Outcome Treatment
    1