BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLUNG KIT 230

    MDR report key: 14429844 · Received May 18, 2022

    Report

    Report Number
    3012172416-2022-00033
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 5, 2022
    Report Date
    June 10, 2022
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    H3 PLANT INVESTIGATION: THE COMPLAINT SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. IT WAS FOUND THAT THE LUER LOCK POSITIVE ADAPTER WAS BROKEN AND THE INNER CONUS OF THE ADAPTER WAS STUCK INSIDE THE RECIRCULATION PORT OF THE OXYGENATOR. THIS DEFECT CAUSED THE DESCRIBED LEAKAGE AND THE BROKEN CONUS MADE IT IMPOSSIBLE TO CONNECT ANOTHER LUER LOCK CONNECTOR TO THE PORT. THE MANUFACTURER CONFIRMED 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 ADAPTER WHICH IS CONNECTED TO THE PORT OF THE OXYGENATOR WAS IDENTIFIED AS THE CAUSE. NO NONCONFORMITIES WERE FOUND DURING REVIEW OF THE MANUFACTURING RECORDS. 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 REPORTED THAT AN XLUNG KIT 230 WAS LEAKING FROM THE ARTERIAL SAMPLE LINE DURING PRIMING. IT WAS REPORTED THAT THE MALE LUER LOCK ON THE ARTERIAL SAMPLE LINE DID NOT FIT TO THE FEMALE CONNECTOR ON THE OXYGENATOR. THE USER ATTEMPTED TO RESOLVE THE ISSUE BY SCREWING THE LUER LOCK ON TIGHTER, BUT THIS DID NOT WORK. NEXT, THEY TRIED USING A DIFFERENT SAMPLE LINE TO PRESERVE THE KIT, BUT THIS ATTEMPT FAILED AS WELL. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT AN XLUNG KIT 230 WAS LEAKING FROM THE ARTERIAL SAMPLE LINE DURING PRIMING. IT WAS REPORTED THAT THE MALE LUER LOCK ON THE ARTERIAL SAMPLE LINE DID NOT FIT TO THE FEMALE CONNECTOR ON THE OXYGENATOR. THE USER ATTEMPTED TO RESOLVE THE ISSUE BY SCREWING THE LUER LOCK ON TIGHTER, BUT THIS DID NOT WORK. NEXT, THEY TRIED USING A DIFFERENT SAMPLE LINE TO PRESERVE THE KIT, BUT THIS ATTEMPT FAILED AS WELL. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2763940 XLUNG KIT 230 QJZ QJZ XENIOS AG 8015302

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown