BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS NOVALUNG NOVALUNG DEVICE FOR ECMO

    MDR report key: 21298096 · Received January 31, 2025

    Report

    Report Number
    MW5165594
    Event Type
    Injury
    Date Received
    January 31, 2025
    Date of Event
    November 13, 2024
    Report Date
    January 29, 2025
    Manufacturer
    FRESENIUS MEDICAL CARE/XENIOS AG
    Product Code
    QJZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NOVALUNG FROM FRESENIUS MEDICAL WAS USED ON A PATIENT ON VA ECMO (VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION). WHEN ON A SWEEP OF 2LPM AND 50% THE POST PO2 (PARTIAL PRESSURE OF OXYGEN) RESULT WAS 69 MM HG. THIS RESULTED IN NEEDING TO SWITCH OUT DEVICE 10 HOURS INTO MEDICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246129 FRESENIUS NOVALUNG NOVALUNG DEVICE FOR ECMO EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATORY / CARDIOPULMONARY FAILURE QJZ FRESENIUS MEDICAL CARE/XENIOS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Life Threatening