BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVALUNG SYSTEM FOR ECMO

    MDR report key: 21298235 · Received January 31, 2025

    Report

    Report Number
    MW5165609
    Event Type
    Injury
    Date Received
    January 31, 2025
    Report Date
    January 30, 2025
    Manufacturer
    FRESENIUS MEDICAL CARE/XENIOS AG
    Product Code
    DWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS ON VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) SUPPORT. ON DAY 4 THE PATIENT WAS WEANING FROM SUPPORT AS THEY WERE ABOUT TO BE DISCONTINUED FROM NEEDING ECMO. DURING A TRIAL TURNDOWN OF SUPPORT THE CIRCUIT COLOR TURNED DARK RED INDICATING NO OXYGENATION BEING CONTRIBUTED VIA THE NOVALUNG DEVICE. THE POST OXY GAS WAS 80 MM OF HG ON 60% VIA THE NOVALUNG DEVICE. THE OXYGEN ON THE DEVICE WAS INCREASED TO 100% AND THE PATIENT WAS SET BACK A FEW DAYS TO RECOVER FROM THIS EVENT. INSTEAD OF SEPARATING FROM THE ECMO CIRCUIT THE PATIENT CONTINUED ON SUPPORT WITH NOVALUNG GAS PARKED AT 100% FIO2. ALSO, THE POST OXY GASES WERE DRAWN EVERY 2 HOURS RESULTING IN VARIABLE RESULTS FROM 89 UP TO 230. THIS PROBLEM WITH THE DEVICE RESULTED IN A DEVIATION OF PRACTICE FROM OUR NORMAL PATIENTS AS THE DEVICE WAS FAILING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246143 NOVALUNG SYSTEM FOR ECMO CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF FRESENIUS MEDICAL CARE/XENIOS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Life Threatening| R