BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLUNG KIT 230

    MDR report key: 14606777 · Received June 6, 2022

    Report

    Report Number
    3012172416-2022-00035
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 12, 2022
    Report Date
    June 6, 2022
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE PRODUCT SAMPLE WAS NOT RETURNED TO THE MANUFACTURER, AND THEREFORE A PHYSICAL EVALUATION COULD NOT BE PERFORMED. A VIDEO WAS PROVIDED SHOWING A LEAK AT THE CONNECTION OF THE VENOUS VENT PORT AND THE VENTING LINE. NO NONCONFORMITIES WERE FOUND DURING REVIEW OF THE MANUFACTURING RECORDS. THE MANUFACTURER CONFIRMS THEY HAVE RECEIVED SIMILAR ERROR MESSAGES ABOUT LEAKS AT THE AFFECTED CONNECTION. THE REPORTED ERROR PATTERN IS KNOWN. A DEFECT AT THE INNER CONUS OF THE LUER LOCK POSITIVE ADAPTER WHICH CONNECTS TO THE PORT OF THE OXYGENATOR WAS IDENTIFIED AS THE CAUSE OF THE REPORTED LEAKAGE. AS THE DAMAGED COMPONENT IS A PURCHASED PART, THE SUPPLIER HAS BEEN INFORMED FOR FURTHER EXAMINATION OF THE ERROR. MEASURES HAVE ALREADY BEEN IMPLEMENTED TO AVOID THIS ERROR IN THE FUTURE.

    Description of Event or Problem · 0

    A USER FACILITY NURSE REPORTED THAT AN EXTERNAL FLUID LEAK OCCURRED DURING THE PRIMING OF AN XLUNG KIT 230 FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) TREATMENT. THE LEAK WAS COMING FROM THE LUER LOCK CONNECTION BETWEEN THE VENT PORT OF THE OXYGENATOR AND THE VENTING LINE. THE CONNECTION WAS NOT LOOSE; IT WAS CONFIRMED TO BE SECURE BEFORE PRIMING STARTED. THE XLUNG KIT WAS INSPECTED FOR DAMAGE PRIOR TO USE AND NO DAMAGE WAS FOUND. NO DAMAGE WAS FOUND AT THE LOCATION OF THE LEAK ONCE IDENTIFIED. THERE WERE NO CONSOLE ALARMS ASSOCIATED WITH THE EVENT. TO RESOLVE THE REPORTED ISSUE, A DIFFERENT KIT WAS USED. THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT AFTER THE KIT WAS REPLACED. THERE WERE NO DELAYED OR MISSED TREATMENTS DUE TO THE REPORTED LEAK. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140509 XLUNG KIT 230 QJZ QJZ XENIOS AG 8014930

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown