BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC3 ECMO OXYGENATOR

    MDR report key: 25240068 · Received May 21, 2026

    Report

    Report Number
    3011468686-2026-00037
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    May 19, 2026
    Report Date
    May 21, 2026
    Manufacturer
    MC3 INC.
    Product Code
    BYS
    PMA / PMN Number
    K191935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, A LEAK WAS OBSERVED FROM THE EXHAUST PORT. THE LEAK WAS REPORTED TO HAVE ORIGINATED FROM THE DEVICE RATHER THAN THE TUBING CONNECTION. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS AND PLASMA BREAKTHROUGH DID NOT OCCUR. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523460 MC3 ECMO OXYGENATOR OXYGENATOR, LONG TERM SUPPORT GREATER THAN 6 HOURS BYS MC3 INC. 48145 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1