BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLUNG KIT 230

    MDR report key: 14281986 · Received May 4, 2022

    Report

    Report Number
    3012172416-2022-00031
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    March 23, 2022
    Report Date
    May 3, 2022
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. THE DESCRIBED SITUATION IS ADEQUATELY ADDRESSED IN THE INSTRUCTION FOR USE (IFU) AND/OR ON THE LABEL. DURING THE MANUFACTURING PROCESS, THE TEMPERATURE PROBES ARE TIGHTENED WITH A TORQUE OF 25 CNM. THIS IS FOLLOWED BY A 100% LEAKAGE TEST OF THE OXYGENATORS. SINCE THIS SEEMS TO BE AN ISOLATED CASE, DETECTING THE FAILURE IN ANY RETENTION SAMPLE IS HIGHLY UNLIKELY. NO NONCONFORMITIES WERE FOUND DURING REVIEW OF THE MANUFACTURING RECORDS. THERE ARE NO SIMILAR COMPLAINTS THAT WERE REPORTED DURING THE PREVIOUS 24 MONTHS. IN CONCLUSION, A DEFECT OF THE XLUNG KIT 230 COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    DURING TRANSPORT OF AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SETUP, THE USER REMOVED THE TEMPERATURE PROBE FROM THE OXYGENATOR. WHILE DOING SO, THE TEMPERATURE PROBE CONNECTOR WAS ACCIDENTALLY DETACHED FROM THE OXYGENATOR AND BLOOD LEAKED OUT OF THE PORT. IT WAS UNKNOWN IF THE BLOOD LEAK WAS CAUSED BY USE ERROR. REPORTEDLY, THE USER DID NOT UNSCREW THE TEMPERATURE PROBE CONNECTOR AT ALL; THE CONNECTOR JUST CAME OFF DURING THE TREATMENT. THE CONNECTOR WAS THEN RE-INSERTED AND FUNCTIONED NORMALLY. IT WAS ALSO UNKNOWN IF THE LEAK WAS CAUSED BY A PRODUCT DEFECT. THE MANUFACTURER ATTEMPTED TO UNSCREW THE CONNECTOR OF ANOTHER USED XLUNG KIT AND IT TOOK ¿SOME EFFORT¿ TO DO SO. THE USER STATED THAT NO MANIPULATION HAD OCCURRED PRIOR TO THE DISCONNECTION. THE OPERATOR'S PRODUCT KNOWLEDGE WAS ACCESSED AND SHOWED ADEQUACY; THEY HAD BEEN USING XENIOS PRODUCT FOR AROUND TWO YEARS. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) VOLUME WAS 500 ML. ALTHOUGH THE PATIENT'S HEMOGLOBIN DROPPED SLIGHTLY, THERE WERE NO REPORTS OF MEDICAL INTERVENTION BEING NEEDED. FOLLOWING THE INCIDENT, THE PATIENT WAS STABLE, AND THEY WERE ABLE TO CONTINUE TREATMENT AFTER THE CONNECTOR WAS REINSTALLED. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393895 XLUNG KIT 230 QJZ QJZ XENIOS AG 8013592

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOVALUNG CONSOLE