BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORE-SIGHT ELITE MODULE

    MDR report key: 14951234 · Received July 7, 2022

    Report

    Report Number
    2015691-2022-06662
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    June 13, 2022
    Report Date
    December 22, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    MUD
    PMA / PMN Number
    K180003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    THE FORE-SIGHT ELITE MODULE WAS RETURNED FOR EVALUATION. THE REPORTED ISSUE OF INACCURATE VALUES WAS CONFIRMED. WHEN CONNECTED TO A KNOWN WORKING SYSTEM AND SENSOR SIMULATORS, THE SENSOR CABLE 2 READ THE CORRECT VALUE OF 65 PERCENT BUT THE SENSOR CABLE 1 READ 18 PERCENT. THERE WAS AN ERROR FOR THE STO2 SIGNAL LEVELS BEING TOO LOW. THE HEM1 MONITOR THEN NO LONGER GAVE A STO2 READINGS FROM SENSOR CABLE 1. THE SIMULATOR WAS DISCONNECTED FROM CABLE 1 AND THE CONTACTS INSIDE THE SENSOR CABLE 1 WERE CHECKED. THERE WAS NO CONTAMINATION OR PHYSICAL DAMAGE FOUND. THE SENSOR SIMULATOR WAS REATTACHED. THE READINGS WERE THEN NORMAL. THE SIMULATOR WAS CONNECTED AND DISCONNECTED MULTIPLE TIMES AND THE ERROR DID NOT RETURN. MOVING AND BENDING THE CABLE 1 DID NOT CAUSE THE ERROR TO RETURN, BUT THE VALUE WOULD OCCASIONALLY FLUCTUATE SLIGHTLY FROM 65 PERCENT TO 64 PERCENT. 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 · 0

    AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. A PRODUCT RISK ASSESSMENT AND A CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS OPENED TO ADDRESS THE INACCURATE VALUES. THE CAPA INVESTIGATION CONCLUDED THAT THE ROOT CAUSE IS A DESIGN DEFECT IN BOTH ALGORITHM VERSIONS (V2.5.7 AND V3.0.7) FOR THE AFFECTED SOMATIC REGIONS WHICH ARE LEGS AND ARMS OR DELTOIDS. AS A RESULT, FCA 89647 WAS INITIATED FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT USING THIS FORE-SIGHT ELITE MODULE, THE MEASURED STO2 VALUE THAT WAS MEASURED ON ONE OF THE CHANNELS WAS LOWER THAN THE OTHER CHANNELS OF THE SAME FSM. WHEN THE CUSTOMER MEASURED THE STO2 OF RIGHT AND LEFT LEGS BY USING THIS FSM, THE STO2 VALUE OF RIGHT LEG (AROUND 40 PERCENT) WAS LOWER THAN EXPECTED AND LOWER THAN THE STO2 VALUE OF LEFT LEG (AROUND 65 PERCENT). WHEN THE CUSTOMER MEASURED THE STO2 OF THE SAME PATIENT BY USING CASMED FSE, THE MEASURED VALUES OF RIGHT AND LEFT LEGS WERE ALMOST SAME (AROUND 65 PERCENT) AND IT ALSO MATCHED THE EXPECTATION OF THE CUSTOMER. WHEN THE CUSTOMER REPLACED THIS FSM WITH ANOTHER FSM, THE MEASURED STO2 VALUE OF RIGHT AND LEFT LEGS OF THE SAME PATIENT WERE ALMOST SAME (AROUND 65 PERCENT). IT IS UNKNOWN WHETHER ANY ERROR MESSAGE WAS DISPLAYED OR NOT. THE CUSTOMER ACKNOWLEDGED THE INFORMATION OF FCA-168 ON (B)(6) 2022 AND HAS RECOGNIZED THAT THE MEASURED STO2 VALUE OF LEG MAY BE INACCURATE, BUT THEY WERE MEASURING THE STO2 OF THE LEG TO MONITOR THE TREND OF THE VALUE. BEFORE HSCX WAS INSTALLED IN THIS HOSPITAL, CASMED FSE HAD BEEN USED. THE PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED BUT UNAVAILABLE. THE PATIENT WAS NOT TREATED BY THE INACCURATE VALUES. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087305 FORE-SIGHT ELITE MODULE OXIMETER, TISSUE SATURATION MUD EDWARDS LIFESCIENCES HEMFSM10 21102655

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown