BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MC3 NATUILUS SMART ECMO OXYGENATOR

    MDR report key: 19609650 · Received June 25, 2024

    Report

    Report Number
    3011468686-2024-00017
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 24, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO RETURN FOR EVALUATION; INVESTIGATION IS ONGOING TO IDENTIFY THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS TESTED. NO DEVICE DEFICIENCY OR MALFUNCTION IDENTIFIED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A NAUTILUS SMART EXTRACORPOREAL MEMBRANE OXYGENATION, IT WAS REPORTED THAT AIR WAS OBSERVED IN THE ARTERIAL SIDE TOP OF THE MEMBRANE ON THE SECOND DAY OF THE PROCEDURE. IT WAS DURING AN INTERVENTIONAL LUNG ASSIST (ILA) PROCEDURE. THE LINES WERE CLAMPED, AND THE AIR WAS REMOVED BY DRAWING ON THE ARTERIAL PORT. THE CUSTOMER STATED THAT THE ISSUE APPEARED TO BE MICRO BUBBLES SLOWLY APPEARING IN THE ARTERIAL SIDE. THE AIR WAS DRAWN OFF FOR A SECOND TIME AND THE ISSUES WENT AWAY FOR A FEW HOURS. HOWEVER, THE ISSUE REAPPEARED OVERNIGHT. THE PATIENT WAS STILL ON SUPPORT; THEREFORE, IT WAS UNCLEAR IF THEY WERE AFFECTED BY THE ISSUE. THE CUSTOMER STATED THAT THE PROCEDURE OF AN INTERVENTIONAL LUNG ASSIST WAS NOT THE TYPICAL USE FOR THE DEVICE, BUT IT SHOULD NOT ENTRAIN AIR IN ANY CASE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A NAUTILUS SMART EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, IT WAS REPORTED THAT AIR WAS OBSERVED IN THE ARTERIAL SIDE ON TOP OF THE MEMBRANE ON THE SECOND DAY OF THE PROCEDURE. IT WAS DURING AN INTERVENTIONAL LUNG ASSIST (ILA) PROCEDURE. THE LINES WERE CLAMPED AND THE AIR WAS REMOVED BY DRAWING ON THE ARTERIAL PORT. THE CUSTOMER STATED THAT THE ISSUE APPEARED TO BE MICRO BUBBLES SLOWLY APPEARING IN THE ARTERIAL SIDE. THE AIR WAS DRAWN OFF FOR A SECOND TIME AND THE ISSUES WENT AWAY FOR A FEW HOURS. HOWEVER, THE ISSUE REAPPEARED OVERNIGHT. THE PATIENT WAS STILL ON SUPPORT, THEREFORE, IT WAS UNCLEAR IF THEY WERE AFFECTED BY THE ISSUE. THE CUSTOMER STATED THAT THE PROCEDURE OF AN INTERVENTIONAL LUNG ASSIST WAS NOT THE TYPICAL USE FOR THE DEVICE BUT IT SHOULD NOT ENTRAIN AIR IN ANY CASE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ROOT CAUSE OF AIR ENTRY WAS NOT DETERMINED. THERE WAS NO BUBBLE DETECTOR USED. THE STAFF ATTEMPTED TO CLEAR THE BUBBLES BY SEPARATING THE PATIENT FROM THE CIRCUIT. THEY PUSHED THE VOLUME POST OXYGENATOR CONNECTOR AND ASPIRATED AT THE TOP OF THE OXYGENATOR. THEY CLEARED THE AIR BUT IT REACCUMULATED. HOURS LATER, THE CUSTOMER ASPIRATED THE AIR OUT TWICE FROM THE TOP OF THE POST OXYGENATOR PIGTAIL WITHOUT CLAMPING OFF THE CIRCUIT. INITIALLY, IT SEEMED EFFECTIVE. HOWEVER, ON NIGHT SHIFT AIR BEGAN APPEARING ON THE POST OXYGENATOR MEMBRANE AGAIN. IT REQUIRED THE CIRCUIT TO BE CHANGED. THE OXYGENATOR WAS PLACED ON AN IV POLE AT OR BELOW PATIENT LEVEL. THERE WERE TIMES WHEN THE DEVICE WAS ABOVE PATIENT LEVEL. THE OXYGENATOR LEVEL WAS NOT CONSISTENTLY AT OR ABOVE THE LEVEL OF THE PATIENT'S HEART AS THE PATIENT WAS MOBILE AND THE DEVICE WAS BEING USED AS AN ILA. THE YELLOW VENT CAP WAS ALWAYS KEPT ON FOR THIS REASON. THERE WAS A STOPPAGE IN BLOOD FLOW WHEN THE CUSTOMER DEAIRED THE DEVICE QUICKLY AS STATED ABOVE. THERE WAS NO RETROGRADE FLOW OBSERVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER DOES NOT WANT TO SEND THE PERFUSION RECORD DUE TO PRIVACY CONCERNS AROUND IDENTIFYING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433051 MC3 NATUILUS SMART ECMO OXYGENATOR NATUILUS SMART OXYGENATOR BYS MC3 INC. 48135 2209267 10854916006871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention