BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XLUNG

    MDR report key: 21197344 · Received January 21, 2025

    Report

    Report Number
    MW5164940
    Event Type
    Injury
    Date Received
    January 21, 2025
    Date of Event
    July 11, 2024
    Report Date
    January 14, 2025
    Manufacturer
    FRESENIUS MEDICAL CARE/ XENIOS AG
    Product Code
    QJZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT DID GET APPROXIMATELY 5 ML OF AIR FROM AN IV DRIP. THE PUMP AND OXYGENATOR FAILED TO CONTINUE FLOW. PATIENT HAD TO BE CLAMPED OFF TO ECMO(EXTRACORPOREAL MEMBRANE OXYGENATION) AND THE AIR WAS MANUALLY EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555720 XLUNG EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATORY / CARDIOPULMONARY FAILURE QJZ FRESENIUS MEDICAL CARE/ XENIOS AG 8016710

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention THE NOVALUNG SYSTEM FOR ECMO