BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLUNG KIT 230

    MDR report key: 13173604 · Received January 5, 2022

    Report

    Report Number
    3012172416-2022-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    December 8, 2021
    Report Date
    February 22, 2022
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE
    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: A1, A2, A4, B5, B7, D4 PLANT INVESTIGATION: THE PRODUCT SAMPLE WAS NOT RETURNED TO THE MANUFACTURER, AND THEREFORE A PHYSICAL EVALUATION COULD NOT BE PERFORMED. NO NONCONFORMITIES WERE FOUND DURING REVIEW OF THE MANUFACTURING RECORDS. IT WAS REPORTED THAT AFTER 30 MINUTES OF TREATMENT, A PRESSURE DROP OF ABOUT 200 MMHG WAS NOTICED AND THAT THE POST-OXYGENATOR HAEMOGAS ANALYSIS WAS PAO2 200 MMHG. THE XLUNG KIT WAS CHANGED TO CONTINUE TREATMENT. THERE ARE CASES IN WHICH, DESPITE FORMALLY SUFFICIENT ADMINISTRATION OF HEPARIN, A SUFFICIENT ELIMINATION OF PLASMATIC COAGULATION WITHIN THE EXTRACORPOREAL CIRCULATION IS HAMPERED. IN SUCH A CASE, A PARTIAL CLOT FORMATION WITH RESULTING DEPOSITION IN THE AREA OF THE FOREIGN MEMBRANE SURFACE OF AN OXYGENATOR CANNOT BE EXCLUDED. AN UNDERLYING CAUSE WHICH MUST BE CONSIDERED IS THE KNOWN MASSIVE COAGULATION PROBLEMS WITH COVID-19 PATIENTS. ADDITIONALLY, AN IMPAIRMENT OF THE GAS EXCHANGE DURING ECMO CAN BE CAUSED BY A LIPID LAYER FORMING ON THE GAS EXCHANGER MEMBRANE. IN COVID-19 PATIENTS, SEDATION WITH PROPOFOL IS KNOWN TO BE RESPONSIBLE FOR HYPERTRIGLYCERIDEMIA IN MECHANICALLY VENTILATED ICU PATIENTS IN GENERAL, BUT ALSO IN PATIENTS SEVERELY DISEASED WITH COVID-19. A CAUSE FOR THE DESCRIBED FAILURE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    APPROXIMATELY THIRTY MINUTES INTO A PATIENT¿S VENO-VENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY, A HIGH PRESSURE VALUE WAS DETECTED ¿PRE MEMBRANE AND A HIGH PRESSURE DROP¿ [SIC]. A PRE-OXYGENATOR PA02 VALUE OF 200 MMHG WAS REPORTED; OTHER DATA WAS NOT PROVIDED. DRAINAGE PRESSURE WAS REPORTEDLY ¿IN THE RANGE¿ [SIC]. TO RESOLVE THE REPORTED PROBLEM, THE PRESSURE WAS CONTROLLED AND THE XLUNG KIT WAS REPLACED. TREATMENT WAS RESTARTED WITH A DIFFERENT DEVICE. THE KIT EXCHANGE RESULTED IN BLOOD LOSS OF APPROXIMATELY 500 ML, AND SEVERE DESATURATION WAS REPORTED. THE EVENT INVOLVED A PATIENT WHO WAS ALREADY ADMITTED IN THE INTENSIVE CARE UNIT (ICU) WITH A SEVERE RESPIRATORY DISEASE DUE TO COVID-19. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING NEEDED DUE TO THE BLOOD LOSS AND/OR DESATURATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Description of Event or Problem · 0

    APPROXIMATELY THIRTY MINUTES INTO A PATIENT¿S VENO-VENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY, A HIGH TRANSMEMBRANE PRESSURE DROP OF ABOUT 200 MMHG WAS NOTICED AND THE POST-OXYGENATOR HAEMOGAS ANALYSIS WAS PA02 200 MMHG. UPON FOLLOW-UP, IT WAS FURTHER CLARIFIED THAT THE DIFFERENCE BETWEEN THE PRE AND POST MEMBRANE PRESSURE WAS ABOUT 200 MMHG. THE PRE-OXYGENATOR PRESSURE WAS 280-300 MMHG AND THE POST-OXYGENATOR PRESSURE WAS 80-100 MMHG. THE CONSOLE ALARMED WITH PRESSURE P2 TOO HIGH (#217) AND PRESSURE P3 TOO HIGH (#231). THERE WERE NO CLOTS NOTED IN THE OXYGENATOR OR TUBING. IT WAS ALSO REPORTED THAT THERE WERE NO ISSUES WITH THE VASCULAR CANNULAS AND NO PROBLEMS WERE ENCOUNTERED DURING CANNULATION. THE PUMP AND OXYGENATOR WERE REPORTEDLY SITUATED BELOW THE PATIENT. AT A BLOOD FLOW OF 4.0 L/MIN, THE DRAINAGE PRESSURE WAS NO MORE THAN 45-50 MMHG, WHICH WAS CONSIDERED TO BE ¿IN THE RANGE¿ [SIC]. TO RESOLVE THE REPORTED PROBLEM, THE PRESSURE WAS CONTROLLED AND THE XLUNG KIT WAS REPLACED. TO CONTROL THE PRESSURE, BLOOD FLOW WAS REDUCED, AND AN IV FLUID BOLUS WAS USED. THE PATIENT RESTARTED ECMO WITH A SEPARATE CIRCUIT THAT HAD BEEN PRIMED ON A DIFFERENT MACHINE. THERE WERE NO ISSUES AFTER SHIFTING TO ANOTHER ECMO MACHINE. THE CHANGE RESULTED IN APPROXIMATELY 600 ML OF BLOOD LOSS, AND SEVERE DESATURATION WAS REPORTED. THE PATIENT WAS ALREADY IN THE INTENSIVE CARE UNIT (ICU) BEING TREATED FOR INTERSTITIAL PNEUMONIA DUE TO COVID-19. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING NEEDED DUE TO THE BLOOD LOSS AND/OR DESATURATION. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED AND LOG FILES WERE NOT AVAILABLE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57185 XLUNG KIT 230 QJZ QJZ XENIOS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male NOVALUNG CONSOLE| NOVALUNG CONSOLE