BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC3 NAUTILUS ECMO OXYGENATOR

    MDR report key: 17372552 · Received July 21, 2023

    Report

    Report Number
    3011468686-2023-00011
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    June 20, 2023
    Report Date
    July 21, 2023
    Manufacturer
    MC3 INC.
    Product Code
    BYS
    UDI-DI
    10854916006888
    PMA / PMN Number
    K191935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO MC3 FOR ANALYSIS. THE REPORTED ISSUE COULD NOT BE REPLICATED. THE INITIAL DECONTAMINATION AND HANDLING OF THE RETURNED DEVICE MAY HAVE HAD AN EFFECT.

    Description of Event or Problem · 0

    ON (B)(6) 2023, AFTER ONE WEEK OF ECMO TREATMENT, THE PERFUSIONIST OBSERVED WATER TRICKLING THROUGH THE HEATER COOLER TO THE NAUTILUS OXYGENATOR. THE HEATER COOLER WAS CHANGED OUT. THIS DID NOT RESOLVE THE ISSUE SO THE OXYGENATOR WAS REPLACED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921438 MC3 NAUTILUS ECMO OXYGENATOR NAUTILUS OXYGENATOR BYS MC3 INC. 48145 2302180 10854916006888

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown