BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC3 ECMO OXYGENATOR

    MDR report key: 23376939 · Received October 24, 2025

    Report

    Report Number
    3011468686-2025-00097
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 20, 2025
    Manufacturer
    MC3 INC.
    Product Code
    BYS
    PMA / PMN Number
    K191935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: VISUAL INSPECTION SHOWS EVIDENCE OF A HOLE IN THE STEM OF THE ARTERIAL LUER CAP. PRESSURE INTEGRITY TESTING WAS PERFORMED AT 3 L/PM WITH 23 PSI, (1189 MMHG) OF BACK PRESSURE FOR 10 MINUTES. DURING THE PRESSURE INTEGRITY TESTING THERE WAS A LEAK OBSERVED FROM THE LUER CAP. REASON FOR THE RETURN WAS CONFIRMED. D.4: SERIAL NUMBER UPDATED. H.6: ANNEX B AND ANNEX C CODES 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 PRIOR TO USE OF THE MC3 NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATOR (ECMO) , A CRACK, BREAK, HOLE WERE OBSERVED IN THE ARTERIAL LUER PORT, WHICH RESULTED IN A SMALL LEAK CAUSING IT TO DRIP DURING PRIMING. A COMPLETE CRACK/BREAK DID NOT OCCUR.ADDITIONALLY, THE ARTERIAL LUER PORT COMPONENT WAS FOUND TO BE LOOSE AND SEPARATED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28288 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