BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC3 ECMO OXYGENATOR

    MDR report key: 23615956 · Received November 21, 2025

    Report

    Report Number
    3011468686-2025-00114
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 29, 2025
    Report Date
    January 30, 2026
    Manufacturer
    MC3 INC.
    Product Code
    BYS
    PMA / PMN Number
    K191935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REVIEW OF THIS EVENT SHOWED THAT THE REPORTED OUT OF BOX HOUSING DAMAGE WAS ACTUALLY LOCATED ON THE DEVICE¿S SHROUD AND THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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

    DEVICE EVALUATION SUMMARY: VISUAL INSPECTION OF THE RETURNED DEVICE SHOWS EVIDENCE OF DAMAGE/CRACK IN THE HOUSING. REASON FOR THE RETURN WAS CONFIRMED. 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 PRIOR TO USE (OUT OF BOX) THE MC3 NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATOR (ECMO) WAS FOUND TO BE DAMAGED AND DEFORMED, WITH THE TOP PART OF THE OXYGENATOR OFF AND BREAKING COMPLETELY WHEN HANDLED AFTER REMOVAL FROM THE PACKAGING. THE DEVICE WAS NOT USED, AND THERE WAS NO DAMAGE TO THE PACKAGING OR TO OTHER DEVICES IN THE SAME SHIPMENT. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED, SO NO ADVERSE EFFECT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2463225 MC3 ECMO OXYGENATOR OXYGENATOR, LONG TERM SUPPORT GREATER THAN 6 HOURS BYS MC3 INC. 48145 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown