BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLUNG KIT 230

    MDR report key: 14115559 · Received April 14, 2022

    Report

    Report Number
    3012172416-2022-00024
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 5, 2022
    Report Date
    April 14, 2022
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE PRODUCT SAMPLE WAS NOT RETURNED FOR PHYSICAL INVESTIGATION. HOWEVER, THE PROVIDED PHOTO SHOWS LEAKAGE AT THE CONNECTION BETWEEN THE VENOUS VENT PORT AND THE VENTING LINE. ALTHOUGH THE CAUSE OF DEATH WAS UNKNOWN, THE HOSPITAL CONFIRMED THAT IT WAS NOT PRODUCT RELATED. IT WAS DETERMINED THAT THE BLOOD LEAK WAS POSSIBLY PRODUCT RELATED. THE DESCRIBED SITUATION IS ADEQUATELY ADDRESSED IN THE INSTRUCTION FOR USE (IFU) AND/OR LABEL. NO NONCONFORMITIES WERE FOUND DURING REVIEW OF THE MANUFACTURING RECORDS. THE LEAKAGE IS AN ERROR PATTERN THAT IS KNOWN, AND MEASURES HAVE ALREADY BEEN IMPLEMENTED TO AVOID THIS ERROR IN THE FUTURE. A DEFECT / SMALL CRACK AT THE INNER CONUS OF THE LUER LOCK POSITIVE ADAPTER, WHICH IS CONNECTED TO THE VENOUS DEAIRING PORT, MOST LIKELY CAUSED THE LEAKAGE. CLINICAL INVESTIGATION: IT IS UNKNOWN IF A TEMPORAL RELATIONSHIP EXISTS BETWEEN ECMO SUPPORT UTILIZING THE XLUNG KIT 230 AND THE PATIENT¿S DEATH AS THERE WAS NO INFORMATION PROVIDED CONCERNING THE TIMING OF THESE EVENTS. THE ROOT CAUSE OF THE PATIENT¿S DEATH CANNOT BE DETERMINED IN THE ABSENCE OF A CONFIRMED SOURCE. THE MAIN COMPLAINT IN THE FILE ADDRESSES THE BLOOD LEAK CAUSED BY A LOOSE LUER LOCK AT THE SWEEP GAS CONNECTION, EVIDENCED BY THE PROVIDED IMAGES. CONSIDERING THE REPORTED BLOOD LOSS AMOUNT, THIS WOULD NOT BE CONSIDERED A LIFE-THREATENING EVENT. THEREFORE, THE PATIENT¿S DEATH CAN BE CONSIDERED UNRELATED TO THE BLOOD LOSS. ADDITIONALLY, THERE WAS NO INDICATION THE PATIENT¿S DEATH WAS RELATED TO ECMO SUPPORT AND THIS WAS CONFIRMED BY THE REPORTING HOSPITAL. IT IS WELL KNOWN ECMO SUPPORT CARRIES A HIGH RISK OF MORTALITY DUE TO MULTIPLE POTENTIAL COMPLICATIONS OF EXTRACORPOREAL SUPPORT. THEREFORE, THE XLUNG KIT 230 CAN BE EXCLUDED AS A POTENTIAL SOURCE OR CONTRIBUTOR TO THIS PATIENT¿S ADVERSE EVENT. BASED ON THE AVAILABLE INFORMATION, THERE WAS NO EVIDENCE THAT ANY FRESENIUS/XENIOS DEVICE DEFICIENCY OR MALFUNCTION CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO FRESENIUS THAT A CRITICALLY ILL PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, WHO WAS UTILIZING THE XLUNG KIT 230 OXYGENATOR, EXPERIENCED MINIMAL BLOOD LOSS DURING ECMO SUPPORT AND SUBSEQUENTLY EXPIRED. THERE WAS NO SPECIFIC ALLEGATION THIS PATIENT¿S DEATH WAS DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS/XENIOS PRODUCT(S) OR DEVICE(S) IN THE INITIAL REPORTING. IT WAS REPORTED THE PATIENT WAS PLACED ON ECMO SUPPORT ON (B)(6) 2022 WHILE ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOLLOWING AN AORTIC DISSECTION. ECMO SUPPORT SETTINGS WERE NOT REPORTED. AFTER 10 MINUTES OF ECMO SUPPORT, A LEAK WAS NOTED AT THE LUER LOCK CONNECTION AT THE SWEEP GAS PORT OF THE XLUNG KIT 230 OXYGENATOR. BLOOD LOSS WAS REPORTEDLY LESS THAN 50ML, AND FURTHER ESTIMATED TO BE ABOUT 10 ML. THE XLUNG KIT 230 WAS USED FOR AN ADDITIONAL THREE DAYS AFTER THE LEAK WAS OCCLUDED WITH GAUZE. AFTER REVIEW OF PHOTOGRAPHIC EVIDENCE PROVIDED BY THE CUSTOMER, IT WAS NOTED THE LUER LOCK CONNECTION TO THE SWEEP GAS PORT WAS NOT COMPLETELY SCREWED IN, EVIDENCED BY A VISIBLE THREAD ON THE MALE CONNECTION OF THE PORT. DETAILS CONCERNING THE PATIENT¿S DEATH WERE NOT REPORTED; HOWEVER, THERE WAS NO INDICATION THIS EVENT WAS RELATED TO THE MINIMAL BLOOD LOSS OR ANY OTHER MALFUNCTION OR DEFICIENCY OF ANY FRESENIUS/ XENIOS DEVICE(S) OR PRODUCT(S). IN FACT, IT WAS CONFIRMED BY THE REPORTING HOSPITAL THE PATIENT¿S DEATH WAS NOT RELATED TO ANY FRESENIUS OR XENIOS PRODUCT(S) AND/OR DEVICE(S) USED. THE XLUNG KIT WAS NOT RETURNED FOR A SAMPLE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2750740 XLUNG KIT 230 QJZ QJZ XENIOS AG 8014703

    Patients

    Seq Age Sex Outcome Treatment
    1 Female NOVALUNG CONSOLE.