BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTRAC SENSOR

    MDR report key: 3973484 · Received August 1, 2014

    Report

    Report Number
    2015691-2014-01758
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT RETURN OF THE ACTUAL COMPLAINT UNIT. THE DPT INSTRUCTIONS FOR USE PROVIDE THE FOLLOWING INFORMATION AND GUIDANCE RELATED TO ABNORMAL PRESSURE READINGS: PRESSURE READINGS CAN CHANGE QUICKLY AND DRAMATICALLY BECAUSE OF LOSS OF PROPER CALIBRATION, LOOSE CONNECTION, OR AIR IN THE SYSTEM. WARNING: ABNORMAL PRESSURE READINGS SHOULD CORRELATE WITH THE PATIENT¿S CLINICAL MANIFESTATIONS. VERIFY TRANSDUCER FUNCTION WITH A KNOWN AMOUNT OF PRESSURE BEFORE INSTITUTING THERAPY. CAUTION: SIGNIFICANT DISTORTION OF THE PRESSURE WAVEFORM OR AIR EMBOLI CAN RESULT FROM AIR BUBBLES IN THE SETUP. NOTE: 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. IT COULD NOT BE DETERMINED IF ANY CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PRESSURE WAVEFORM SHOWN ON THE PHILLIPS PATIENT MONITOR MOVED UP AND DOWN UNSTABLY DURING OPERATION, ALTHOUGH THE PATIENT WAS IN STABLE CONDITION. IT COULD NOT BE CONFIRMED FOR HOW LONG THE MEASUREMENT WAS ACCURATE. THE ACTUAL VALUE SHOWN ON THE MONITOR COULD NOT BE OBTAINED, HOWEVER, IT WAS NOTED THAT THERE WAS ABOUT A 20MMHG DIFFERENCE WITH THE VALUE MEASURED WITH MANCHETTE. TROUBLE SHOOTING WAS PERFORMED BY ZEROING SEVERAL TIMES. ALTHOUGH, IT SOMETIMES ZEROED AND ZEROING ERROR MESSAGES APPEARED, IT WAS UNABLE TO ZERO OR DISPLAY MINUS VALUES. THERE WERE NO ERROR MESSAGES SHOWN ON THE EV1000 MONITOR. THE CABLE WAS REPLACED BUT THE PROBLEM WAS NOT SOLVED. ONCE THE FLOTRAC SENSOR WAS EXCHANGED, THE PROBLEM WAS SOLVED. THERE WERE NO OCCLUSION, LEAKAGE, OR KINKS OBSERVED ON THE TUBING. IT WAS FURTHER STATED THAT IT WAS NOT POSSIBLE TO CONFIRM WHETHER THE WAVEFORM AND VALUE MATCHED OR NOT. THE ACTUAL VALUE SHOWN ON THE MONITOR IS UNKNOWN AND DATA WAS NOT AVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450822 FLOTRAC SENSOR TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS EDWARDS LIFESCIENCES DR MHD6S 59733626

    Patients

    Seq Age Sex Outcome Treatment
    1