BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLUNG KIT 230

    MDR report key: 24267420 · Received February 5, 2026

    Report

    Report Number
    3012172416-2026-00007
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 21, 2026
    Report Date
    March 24, 2026
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    UDI-DI
    04057224001494
    PMA / PMN Number
    K191407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINTS HAVE BEEN REPORTED ABOUT THIS BATCH NUMBER. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. USERS ARE INSTRUCTED TO UTILIZE DE-AIRING TECHNIQUES DURING PRIMING AND PRIOR TO PATIENT APPLICATION TO ENSURE PATIENT SAFETY. AS AIR CAN ONLY BE ENTRAINED WHILE THE CIRCUIT IS OPEN TO ATMOSPHERE DURING PRIMING AND SHOULD BE CLOSED UNTIL PATIENT APPLICATION, IT WAS DETERMINED THAT THE EVENT WAS AN UNINTENDED USER ERROR.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT AN XLUNG KIT 230 WAS PRIMED FOR BACKUP TO AN ACTIVELY SUPPORTED EXTRACORPOREAL MEMBRANE OXYGENATION PATIENT. IT CIRCULATED SINCE (B)(6) 2026, WITH A CLOSED CIRCUIT WITHOUT THE FILLING LINE. ON (B)(6) 2026, AIR WAS DETECTED IN THE OXYGENATOR, PUMP HEAD AND IN PARTS OF THE PATIENT CIRCUIT. DURING VISUAL INSPECTION ON SITE, NO DAMAGE TO THE KIT WAS NOTED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT AN XLUNG KIT 230 WAS PRIMED FOR BACKUP TO AN ACTIVELY SUPPORTED EXTRACORPOREAL MEMBRANE OXYGENATION PATIENT. IT CIRCULATED SINCE JANUARY 12, 2026, WITH A CLOSED CIRCUIT WITHOUT THE FILLING LINE. ON JANUARY 21, 2026, AIR WAS DETECTED IN THE OXYGENATOR, PUMP HEAD AND IN PARTS OF THE PATIENT CIRCUIT. DURING VISUAL INSPECTION ONSITE, NO DAMAGE TO THE KIT WAS NOTED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION; HOWEVER, THE DEVICE WAS NOT RETURNED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326746 XLUNG KIT 230 EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATORY / CARDIOPULMONARY FAILURE QJZ XENIOS AG GSXG1403 04057224001494

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown