BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC3 ECMO OXYGENATOR

    MDR report key: 23801302 · Received December 15, 2025

    Report

    Report Number
    3011468686-2025-00118
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    December 8, 2025
    Report Date
    March 3, 2026
    Manufacturer
    MC3 INC.
    Product Code
    BYS
    PMA / PMN Number
    K191935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THIS APPEARS TO BE AN ELECTRONICS ISSUE BUT THE CUSTOMER IS UNSURE GIVEN THE GAS TRANSFER NUMBERS. CORRECTION D8 (WAS DEV SERVICED BY THIRD PARTY?): THIS FIELD HAS BEEN UPDATED. CORRECTION H3 (DEVICE EVALUATED?): THIS FIELD HAS BEEN 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.

    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 AN MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, A GAS TRANSFER ISSUE OCCURRED. PRE AND POST OXYGENATOR SATURATIONS WILL DRIFT, EVEN THOUGH THEY ARE CALIBRATING THEM DAILY AND UPDATE THEM WHEN HCT CHANGES. FOR EXAMPLE, THIS SATURATION PRE-OXYGENATOR WAS 100 FOR HOURS ON END, EVEN AFTER CALIBRATION AND SOMETIMES HIGHER ON THE PRE-OXYGEN ATOR THAN THE POST-OXYGENATOR SIDE. THE DEVICE WAS NOT DAMAGED. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606791 MC3 ECMO OXYGENATOR OXYGENATOR, LONG TERM SUPPORT GREATER THAN 6 HOURS BYS MC3 INC. 48135

    Patients

    Seq Age Sex Outcome Treatment
    1