BEUDAMED
    FDA Adverse Event Death Summary report: N

    MC3 NAUTILUS SMART ECMO OXYGENATOR

    MDR report key: 19605079 · Received June 25, 2024

    Report

    Report Number
    3011468686-2024-00015
    Event Type
    Death
    Date Received
    June 25, 2024
    Date of Event
    April 23, 2024
    Report Date
    June 22, 2024
    Manufacturer
    MC3 INC. (MEDTRONIC DEXTER)
    Product Code
    BYS
    PMA / PMN Number
    K191935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. INVESTIGATION IS ONGOING TO IDENTIFY THE REPORTED ISSUE.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT THE PATIENT WAS SUPPORTED FOR 72 HOURS WITH NO ISSUES, THEN THE DELTA PRESSURE ROSE FROM 30MMHG TO 45MMHG WITHIN 2 HOURS AND UP TO 65MMHG IN THE NEXT HOUR. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THE ORIGINAL NAUTILUS WAS RINSED, AND NO VISIBLE CLOT WAS OBSERVED ON THE VENOUS OR ARTERIAL SIDE OF THE MEMBRANE. THE PATIENT IS DECEASED, THE CAUSE OF DEATH AND CIRCUMSTANCES SURROUNDING THE DEATH WERE BIVENTRICULAR FAILURE, UNSUCCESSFUL EXTRACORPOREAL LIFE SUPPORT (ECLS) OUTCOME. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE HCP REPORTED THAT THEY WERE NOT USING THE SMART MONITOR TO MEASURE THE PRESSURES. THE CUSTOMER USED EXTERNAL TRANSDUCERS FOR MEASUREMENT. THE DELTA PRESSURE WAS AROUND 30 MMHG, NOTED FOR 72 HOURS BEFORE THE RISING DELTA PRESSURE WAS SEEN. THE CUSTOMER DID NOT USE THE DELTA P ON THE SMART NAUTILUS. THE CIRCUIT PRESSURE WAS NORMAL, DELTA PRESSURE OF 30MMHG. THE SMART ECMO MODULE WAS NOT USED, THEREFORE IT WAS NOT AFFECTED BY ANY RF EMITTER. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DATA ARE FROM THE SCPC AND NOT THE NAUTILUS (SCPC IS THE PUMP SYSTEM). THE PATIENT WAS IN SEVERE SHOCK LIVER. HEPARIN WAS OFF AT THE TIME OF THE INCREASE IN DELTA P. THE CUSTOMER STATED THAT FIBRIN WAS NOTED ON THE PRE-OXYGENATOR SIDE (MOSTLY AT THE TOP). HEPARIN WAS GIVEN IN THE DAYS BEFORE TO KEEP A PTT 60-90SECONDS BUT WAS OFF DUE TO HER SHOCK LIVER AND PTT > 140SEC. THE PATIENT ALSO HAD A VERY ELEVATED INR. THE CUSTOMER DOES NOT RUN ACT ON ECMO, THEY MEASURE PTT. THE PATIENT ALSO HAD THALASSEMIA TRAIT.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT THE PATIENT WAS SUPPORTED FOR 72 HOURS WITH NO ISSUES, THEN THE DELTA PRESSURE ROSE FROM 30MMHG TO 45MMHG WITHIN 2 HOURS AND UP TO 65MMHG IN THE NEXT HOUR. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THE ORIGINAL NAUTILUS WAS RINSED, AND NO VISIBLE CLOT WAS OBSERVED ON THE VENOUS OR ARTERIAL SIDE OF THE MEMBRANE. THE PATIENT IS DECEASED, THE CAUSE OF DEATH AND CIRCUMSTANCES SURROUNDING THE DEATH WERE BIVENTRICULAR FAILURE, UNSUCCESSFUL EXTRACORPOREAL LIFE SUPPORT (ECLS) OUTCOME. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE HCP REPORTED THAT THEY WERE NOT USING THE SMART MONITOR TO MEASURE THE PRESSURES. THE CUSTOMER USED EXTERNAL TRANSDUCERS FOR MEASUREMENT. THE DELTA PRESSURE WAS AROUND 30 MMHG, NOTED FOR 72 HOURS BEFORE THE RISING DELTA PRESSURE WAS SEEN. THE CUSTOMER DID NOT USE THE DELTA P ON THE SMART NAUTILUS. THE CIRCUIT PRESSURE WAS NORMAL, DELTA PRESSURE OF 30MMHG. THE SMART ECMO MODULE WAS NOT USED, THEREFORE IT WAS NOT AFFECTED BY ANY RF EMITTER. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DATA ARE FROM THE SCPC AND NOT THE NAUTILUS (SCPC IS THE PUMP SYSTEM). THE PATIENT WAS IN SEVERE SHOCK LIVER. HEPARIN WAS OFF AT THE TIME OF THE INCREASE IN DELTA P. THE CUSTOMER STATED THAT FIBRIN WAS NOTED ON THE PRE-OXYGENATOR SIDE (MOSTLY AT THE TOP). HEPARIN WAS GIVEN IN THE DAYS BEFORE TO KEEP A PTT 60-90SECONDS BUT WAS OFF DUE TO HER SHOCK LIVER AND PTT > 140SEC. THE PATIENT ALSO HAD A VERY ELEVATED INR. THE CUSTOMER DOES NOT RUN ACT ON ECMO, THEY MEASURE PTT. THE PATIENT ALSO HAD THALASSEMIA TRAIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435537 MC3 NAUTILUS SMART ECMO OXYGENATOR NAUTILUS OXYGENATOR BYS MC3 INC. (MEDTRONIC DEXTER) 48135 2209132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death