BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLUNG KIT 230

    MDR report key: 22607981 · Received July 25, 2025

    Report

    Report Number
    3012172416-2025-00073
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    July 3, 2025
    Report Date
    October 28, 2025
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    UDI-DI
    04057224001494
    PMA / PMN Number
    K191407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D4, D9, H3. PLANT INVESTIGATION: A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NON-CONFORMITIES DURING THE MANUFACTURING PROCESS. INVESTIGATION OF THE RETURNED SAMPLES SHOWED THAT THE TRANSFER RATE FOR OXYGEN WAS WITHIN SPECIFICATION, AND NO EVIDENCE OF OXYGENATION IMPAIRMENT DUE TO DEVICE MALFUNCTION WAS IDENTIFIED. A MINOR CARBON DIOXIDE TRANSFER DEVIATION LIKELY REFLECTED MEASUREMENT VARIABILITY AND IS NOT EXPECTED TO AFFECT OXYGEN TRANSFER EFFICIENCY. A DEFINITIVE CAUSE FOR THE REPORTED SUBOPTIMAL OXYGENATION CANNOT BE DETERMINED. THE CAUSE FOR LOW POST-OXY PARTIAL OXYGEN PRESSURE OR LOW OXYGENATOR PERFORMANCE CAN BE PRODUCT AS WELL AS APPLICATION AND/OR PATIENT RELATED. THE ABSENCE OF DELTA PRESSURE INCREASES, OR VISUAL CLOTTING SUGGESTS NO SIGNIFICANT FIBER OBSTRUCTION OR THROMBUS FORMATION. GIVEN THE HIGH POST OXYGENATOR SATURATION OF OXYGEN OF 99% AND 100% AND SIMULTANEOUSLY LOW SYSTEMIC SAO2 (LOWEST 58%), POTENTIAL CONTRIBUTING FACTORS EXTERNAL TO THE OXYGENATOR MAY HAVE INFLUENCED OXYGEN DELIVERY SUCH ELEVATED OXYGEN CONSUMPTION OR SHUNT FRACTION ASSOCIATED WITH SEVERE ARDS.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT THE MENTIONED XENIOS DEVICES HAVE BEEN USED ON A 13-YEAR-OLD PATIENT WITH SEVERE ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS). THE PATIENT WAS INITIALLY ON VENO-ARTERIAL (VA) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THEN TRANSITIONED TO VENO-ARTERIAL VENOUS (VAV) ECMO SUPPORT WITH A FRACTION OF INSPIRED OXYGEN (FIO2) OF 100% FROM A GAS BLENDER AND THE SWEEP GAS VARIED FROM 3 TO 6 L/MIN. ECMO SUPPORT STARTED ON (B)(6) 2025, THE FOLLOWING WERE POST-OXYGENATOR GASES MEASURED SINCE THE BEGINNING OF SUPPORT (ALL IN MMHG): ON THURSDAY, (B)(6) 2025 - 272, 275, 370, 282, 371; ON FRIDAY (B)(6) 2025 - 418, 281; ON SATURDAY (B)(6) 2025 - 251, 247, 270; ON SUNDAY (B)(6) 2025 ¿ 184, 177. THE CIRCUIT WAS CHANGED WHICH RESULTED IN 234 AND 235. ON MONDAY (B)(6) 2025 - 201, 92, AND THE CIRCUIT WAS EXCHANGED AGAIN, RESULTING IN 156 AND 130. THE USER ADDED A BYPASS OXYGENATOR IN PARALLEL TO PROVIDE ADEQUATE OXYGENATION TO THE PATIENT. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL THAT COULD PROVIDE ECMO SUPPORT WITH A COMPETITOR DEVICE (CARDIOHELP).

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT THE MENTIONED XENIOS DEVICES HAVE BEEN USED ON A 13-YEAR-OLD PATIENT WITH SEVERE ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS). THE PATIENT WAS INITIALLY ON VENO-ARTERIAL (VA) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THEN TRANSITIONED TO VENO-ARTERIAL VENOUS (VAV) ECMO SUPPORT WITH A FRACTION OF INSPIRED OXYGEN (FIO2) OF 100% FROM A GAS BLENDER AND THE SWEEP GAS VARIED FROM 3 TO 6 L/MIN. ECMO SUPPORT STARTED ON (B)(6) 2025, THE FOLLOWING WERE POST-OXYGENATOR GASES MEASURED SINCE THE BEGINNING OF SUPPORT (ALL IN MMHG): ON THURSDAY, (B)(6) 2025 - 272, 275, 370, 282, 371; ON FRIDAY (B)(6) 2025 - 418, 281; ON SATURDAY (B)(6) 2025 - 251, 247, 270; ON SUNDAY (B)(6) 2025 ¿ 184, 177. THE CIRCUIT WAS CHANGED WHICH RESULTED IN 234 AND 235. ON MONDAY (B)(6) 2025 - 201, 92, AND THE CIRCUIT WAS EXCHANGED AGAIN, RESULTING IN 156 AND 130. THE USER ADDED A BYPASS OXYGENATOR IN PARALLEL TO PROVIDE ADEQUATE OXYGENATION TO THE PATIENT. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL THAT COULD PROVIDE ECMO SUPPORT WITH A COMPETITOR DEVICE (CARDIOHELP). THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966734 XLUNG KIT 230 EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATORY / CARDIOPULMONARY FAILURE QJZ XENIOS AG FSXD0204, 04057224001494

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male NOVALUNG CONSOLE (LINUX BOARD).