BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC3 ECMO OXYGENATOR

    MDR report key: 23277635 · Received October 15, 2025

    Report

    Report Number
    3011468686-2025-00084
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 6, 2025
    Report Date
    November 5, 2025
    Manufacturer
    MC3 INC.
    Product Code
    BYS
    PMA / PMN Number
    K191935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FDC CODE UPDATED 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.

    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

    IT WAS REPORTED THAT DURING USE OF THE MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, A BLOOD LEAK WAS OBSERVED FROM THE PINK CAP ON POST-MEMBRANE. THE PATIENT HAD TO BE CLAMPED OFF OF ECMO BRIEFLY WHILE THE CAP WAS CHANGED OUT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS LESS THAN 10ML OF PATIENT BLOOD LOSS AS A RESULT OF THIS LEAK. AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED. IT WAS STATED THAT THIS WAS AN OXYGENATOR EXCHANGE. THE OXYGENATOR WAS PRIMED MINUTES BEFORE THE OXYGENATOR EXCHANGE. THE CIRCUIT WAS PRIMED WITH LACTATED RINGERS. NO ANTI-COAGULANT/CHEMICALS/DRUGS WERE USED IN PRIME OR DURING THE CASE. THERE WAS NO DAMAGE TO THE PACKAGING OR DEVICE IDENTIFIED. THE LEAK STARTED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233482 MC3 ECMO OXYGENATOR OXYGENATOR, LONG TERM SUPPORT GREATER THAN 6 HOURS BYS MC3 INC. 48145 2503331

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male