BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLUNG KIT 230

    MDR report key: 11632322 · Received April 7, 2021

    Report

    Report Number
    3012172416-2021-00005
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 15, 2021
    Report Date
    April 8, 2021
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURING RECORDS WERE REVIEWED, AND NO IRREGULARITIES WERE IDENTIFIED. A REVIEW OF THE RESPECTIVE BATCH RECORDS FOR THE XLUNG KIT 230 AND THE OXYGENATOR DID NOT SHOW ANY EVIDENCE OF A NON-CONFORMANCE DURING THE MANUFACTURING PROCESS. AT THE BEGINNING OF THE PATIENT¿S THERAPY, THE PERFORMANCE WAS LOW AND JUST SUFFICIENT WITH A VALUE FOR PO2 OF 120-130 MMHG AND OXYGEN SATURATION OF 99-100%. IN GENERAL, THE PERFORMANCE OF THE PRODUCT DECREASES OVER THE COURSE OF THE THERAPY DUE TO COAGULATION-RELATED DEPOSITS ON THE MEMBRANE SURFACE. SHOULD THE GAS TRANSFER BE OBSTRUCTED BY DEPOSITS, AN IMPROVEMENT IS USUALLY POSSIBLE WITH A PRODUCT CHANGE. HOWEVER, THIS WAS NOT THE CASE AND THE VALUES IMPROVED ONLY AFTER ANOTHER CHANGE TO A DIFFERENT PRODUCT. DUE TO THE HYPOXIC SITUATION OF THE PATIENT, THE EXCHANGE OF THE PRODUCT IS UNDERSTANDABLE TO AVOID A CRITICAL DETERIORATION OF THE CONDITION. A CAUSE FOR THIS ISSUE COULD NOT BE FOUND AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED. HOWEVER, A PROBLEM WITH BOTH PRODUCTS CANNOT BE EXCLUDED. CLINICAL INVESTIGATION: BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF A SERIOUS INJURY, PATIENT DEATH, OR OTHER ADVERSE EVENT RELATED TO A FRESENIUS AND/OR XENIOS PRODUCT OR OTHER ISSUE WARRANTING FURTHER INVESTIGATION. THEREFORE, THE COMPLETION OF A CLINICAL INVESTIGATION IS NOT WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    A HOSPITAL INTENSIVIST MEDICAL DOCTOR (MD) REPORTED TO FRESENIUS THAT A CRITICALLY ILL PATIENT PLACED ON VENO-VENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PRODUCED SUBOPTIMAL OXYGENATION WHILE UTILIZING THE XLUNG 230 KIT. THERE WAS AN ALLEGATION THIS EVENT WAS RELATED TO AN UNDERPERFORMANCE OF THE XENIOS XLUNG 230 KIT WHICH REQUIRED A REPLACEMENT OXYGENATOR. INFORMATION PROVIDED AT INTAKE AND OBTAINED THROUGH FOLLOW UP INDICATES THE PATIENT WAS HOSPITALIZED AND DIAGNOSED WITH SEVERE ACUTE RESPIRATORY DISTRESS SYNDROME CAUSED BY A COVID-19 INFECTION (DATE NOT REPORTED). THE PATIENT WAS CANNULATED WITH A MAQUET 23 FR. DUAL LUMEN VASCULAR CATHETER AND PLACED ON VV ECMO FOR OXYGENATION SUPPORT. THE PATIENT WAS MEDICATED WITH MIDAZOLAM, FENTANYL, A NEUROMUSCULAR BLOCK (UNKNOWN TYPE), BIVALIRUDIN AND NOREPINEPHRINE (UNKNOWN ROUTES, DOSAGES, FREQUENCIES AND DURATIONS). UPON THE FIRST BLOOD SAMPLING, OXYGEN LEVELS WERE DETERMINED TO BE SUBOPTIMAL AS THE SAMPLE PRESENTED BLOOD OXYGEN AT LESS THAN 200 MMHG (EXACT LEVEL NOT REPORTED) IN CONTRAST TO THE EXPECTED LEVELS OF 300 TO 500 MMHG. THE BLOOD FLOW WAS ADJUSTED TO 4.5 L/MIN AND SWEEP GAS WAS SET TO 100% FIO2 AT 5L/MIN. THE XLUNG 230 KIT OXYGENATOR WAS EXCHANGED FOR THE SAME MODEL OXYGENATOR, AND THIS TOO PRODUCED SUBOPTIMAL BLOOD OXYGEN LEVELS AROUND 200 MMHG (EXACT LEVEL NOT REPORTED). THE OXYGENATOR WAS EXCHANGED FOR A THIRD TIME TO A MAQUET ROTAFLOW WHICH PRODUCED BLOOD OXYGEN LEVELS GREATER THAN 400 MMHG. IT WAS REPORTED THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT, BLOOD LOSS, ADDITIONAL SYMPTOMS OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. ADDITIONALLY, NO ALARMS WERE NOTED ON THE ECMO MACHINE. THE PATIENT¿S TOTAL ECMO RUN TIME, HOSPITAL CARE PROGRESS AND CURRENT DISPOSITION WERE NOT REPORTED. THE SAMPLE XLUNG 230 KIT WAS UNAVAILABLE FOR PRODUCT INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529368 XLUNG KIT 230 QJZ QJZ XENIOS AG 8013561

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR