BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MC3 NAUTILUS SMART ECMO OXYGENATOR

    MDR report key: 17365649 · Received July 20, 2023

    Report

    Report Number
    3011468686-2023-00010
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    June 17, 2023
    Report Date
    August 9, 2024
    Manufacturer
    MC3 INC.
    Product Code
    BYS
    UDI-DI
    10854916006871
    PMA / PMN Number
    K191935
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INSPECTION OF THE RETURNED DEVICE CONFIRMED EVIDENCE OF BLOOD IN THE SENSOR AREA. THIS IS CONSISTENT WITH THE REPORTED BLOOD LEAK. THE INVESTIGATION HAS NOT YET CONCLUDED.

    Additional Manufacturer Narrative · 0

    INSPECTION OF THE RETURNED DEVICE CONFIRMED EVIDENCE OF BLOOD IN THE SENSOR AREA. THIS IS CONSISTENT WITH THE REPORTED BLOOD LEAK. THE DEVICE PASSED LEAK TEST AND INSPECTION DURING ASSEMBLY. DEVICE EVALUATION FOUND A A SMALL VOID IN THE ADHESIVE SURROUNDING THE SENSOR WHICH MAY HAVE LED TO THE OCCURANCE OF THE LEAK.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT FOR ADDITIONAL INFORMATION IN B1(ADVERSE EVENT), B2 (REQUIRED INTERVENTION...), B4 (DATE OF REPORT). CORRECTION TO D3 AND G1 (CONTACT INFORMATION), AND H1 (CHANGE FROM MALFUNCTION TO SERIOUS INJURY).

    Description of Event or Problem · 0

    ON (B)(6) 2023, DURING INITIATION OF ECMO BLOOD BEGAN TO COME OUT OF A NAUTILUS OXYGENATOR NEAR THE HOLDER. THE BLOOD APPEARED INSIDE THE SENSOR AREA. THE OXYGENATOR WAS CHANGED OUT WITH NO ISSUES. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 0

    ON 17-JUN-2023, DURING INITIATION OF ECMO BLOOD BEGAN TO COME OUT OF A NAUTILUS OXYGENATOR NEAR THE HOLDER. THE BLOOD APPEARED INSIDE THE SENSOR AREA. THE OXYGENATOR WAS CHANGED OUT WITH NO ISSUES. THERE WERE NO ADVERSE PATIENT EFFECTS.ADDITIONAL INFORMATION INDICATED THE DEVICE WAS USED FOR 15 HOURS PRIOR TO THE REPORTED LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36023 MC3 NAUTILUS SMART ECMO OXYGENATOR NAUTILUS SMART OXYGENATOR BYS MC3 INC. 48135 2301124 10854916006871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention