BEUDAMED
    FDA Adverse Event Death Summary report: N

    MC3 NAUTILUS ECMO OXYGENATOR

    MDR report key: 18268109 · Received December 5, 2023

    Report

    Report Number
    3011468686-2023-00025
    Event Type
    Death
    Date Received
    December 5, 2023
    Date of Event
    November 8, 2023
    Report Date
    December 5, 2023
    Manufacturer
    MC3 INC.
    Product Code
    BYS
    PMA / PMN Number
    K191935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DISCARDED THE DEVICE. THE REPORTER INDICATED THAT HE DID NOT BELIEVE THE ALLEGED OXYGENATOR ISSUE RESULTED IN THE PATIENT'S DEATH. THE REPORTER ALSO "CONFERRED WITH THE SURGEON AND OTHER PERFUSIONISTS ON THE TEAM AND BELIEVES THAT THERE MUST HAVE BEEN SOME SIGNIFICANT CLOT THAT CAME LOOSE AFTER THE IMPELLA REMOVAL." . FOLLOW-UP WAS REQUESTED; HOWEVER, THE REPORTER INDICATED NO FURTHER INFORMATION WOULD BE PROVIDED. THEREFORE,NO ASSESSMENT CAN BE MADE WITHOUT MORE INFORMATION AND/OR AN ANALYSIS OF THE DEVICES.

    Description of Event or Problem · 0

    ON 28-OCT-2023, PERIPHERAL VA ECMO WAS INITIATED WITH A NAUTILUS OXYGENATOR AND AN IMPELLA. ON (B)(6) 2023, THE CLINICAL TEAM REMOVED THE IMPELLA AND THE POST OXYGENATOR BLOOD TURNED DARK INSTANTLY. ALL ATTEMPTS TO CHECK FOR REASONS FOR THIS WERE NEGATIVE. IT WAS REPORTED THAT WITHIN AN HOUR OR SO AFTER THIS, THE OXYGENATOR "FAILED", UNDEFINED. THE OXYGENATOR WAS CHANGED AND THEN PERFORMED NORMALLY. THE PATIENT EXPIRED LATER THAT NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029735 MC3 NAUTILUS ECMO OXYGENATOR NAUTILUS OXYGENATOR BYS MC3 INC. 48145 2304136

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death