BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV1000 PLATFORM

    MDR report key: 6187085 · Received December 19, 2016

    Report

    Report Number
    2015691-2016-03804
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 25, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    PMA / PMN Number
    K100709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE EVALUATED; HOWEVER, AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO COMMUNICATE THE RESULTS OF THE COMPLAINT INVESTIGATION RESULTS. AN MDR NUMBER WITH REGARD TO THE FLOTRAC SENSOR WILL ALSO BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    ON DECEMBER 5TH, AN EDWARDS CLINICAL SPECIALIST PROVIDED PHOTOS OF THE TPTD IMAGES DISPLAYED ON THE SCREEN DURING THE PATIENT MONITORING PERIOD. AT THIS TIME, THE MONITOR RESIDES IN BRAZIL AND RETURN OF THE DEVICE IS NOT ANTICIPATED; HOWEVER, SEVERAL IMAGES HAVE BEEN RECEIVED FOR CONSIDERATION. IN THE CLINICIAN'S OPINION, THE DISPLAYED VALUES WERE NOT REPRESENTATIVE OF THE PATIENTS CLINICAL STATUS. THE SERIAL NUMBER OF THE MONITOR WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED. WITHOUT RETURN OF THE DEVICE, THE CUSTOMER¿S ALLEGATION IS UNABLE TO BE CONFIRMED OR NEGATED. SHOULD THE DEVICE BE RETURNED FOR EVALUATION, THE FILE WILL BE AMENDED WITH THE NEW INFORMATION AND A FOLLOW-UP SUBMISSION WILL BE COMMUNICATE THE RESULTS. WHILE THE SUSPECTED INACCURATE VALUES WERE SPECULATIVE, SEEING THAT THE CLINICAL PATIENT SCENARIO APPEARED TO HAVE IMPROVED AND THE SCREEN WAS NOT REFLECTIVE OF SUCH, IT IS IMPORTANT TO NOTE THAT WITH ANY HEMODYNAMIC MONITORING, PRESSURE READINGS CAN CHANGE QUICKLY AND DRAMATICALLY. HOWEVER, PRESSURE READINGS SHOULD CORRELATE WITH THE PATIENT'S CLINICAL MANIFESTATIONS. AT THIS TIME, IT IS UNKNOWN WHETHER USER OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. 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. NO CORRECTIVE OR PREVENTATIVE ACTIONS WILL BE PURSUED AT THIS TIME. PLEASE SEE 2015691-2016-03824 FOR THE SYSTEM-RELATED VOLUMEVIEW SENSOR ASSOCIATED WITH THIS EVENT. EDWARDS ANTICIPATES RETURN AND EVALUATION OF THE SENSOR; AT THIS TIME THE RETURN IS PENDING.

    Description of Event or Problem · 1

    AS REPORTED, DURING USE OF A VOLUMEVIEW CATHETER IN A PATIENT WITH SEPTIC SHOCK, THE CLINICIAN SUSPECTED THAT THE ELWI (EXTRAVASCULAR LUNG WATER INDEX) WAS INACCURATE. THE PATIENT WAS RECEIVING CONTINUOUS DIALYSIS THERAPY THROUGH A CVC CATHETER WHILE BEING HEMODYNAMICALLY MONITORED. THE PATIENT¿S RESPIRATORY FUNCTION AND ARTERIAL BLOOD GASSES WERE IMPROVED, AND THE PATIENT WAS BEING WEANED FROM MECHANICAL VENTILATION, YET THE EV1000 MONITOR STILL SHOWED A HIGH ELWI. THERE WAS NO ALERT OR ERROR MESSAGE DISPLAYED ON THE MONITOR. AN EDWARDS CLINICAL SPECIALIST, ALONG WITH THE CLINICIAN, PERFORMED TPTD (TRANSPULMONARY THERMODILUTION), AND RECEIVED ACCURATE TPTD VALUES DURING THE PROCEDURE. INQUIRED OF PATIENT DEMOGRAPHICS, UNABLE TO BE OBTAINED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837507 EV1000 PLATFORM COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION DXG EDWARDS LIFESCIENCES EV1000M

    Patients

    Seq Age Sex Outcome Treatment
    1 VOLUMEVIEW CATHETER