BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVALUNG CONSOLE (LINUX BOARD)

    MDR report key: 12485694 · Received September 16, 2021

    Report

    Report Number
    3012172416-2021-00034
    Event Type
    Death
    Date Received
    September 16, 2021
    Date of Event
    August 22, 2021
    Report Date
    November 19, 2021
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE SUPERVISOR BOARD WAS RETURNED FOR PHYSICAL EVALUATION. THE SUPERVISOR BOARD WAS INSPECTED VISUALLY AND WAS FOUND TO BE IN GOOD CONDITION. THERE WERE NO TRACES OF MOISTURE OR ANY OTHER EXTERNAL INFLUENCE, AND NO SMOKE OR BURN TRACES. FOLLOWING THE VISUAL INSPECTION, FUNCTIONAL TESTING WAS PERFORMED. AFTER CONNECTING THE BOARD TO A CONTROL PANEL AND POWERING ON THE CONSOLE, THE SUPERVISOR BOARD BEGAN ¿BEEPING¿ CONTINUOUSLY. THE HMI AND DISPLAY WAS INACTIVE. NO CAN COMMUNICATION WAS RECEIVED FROM SUPERVISOR BOARD. VOLTAGE MEASURING SHOWED THAT THE INPUT VOLTAGE TO THE SUPERVISOR WAS ACCORDING TO SPECIFICATION. THE SUPERVISOR CONVERTED 5V FOR THE SAFETY CIRCUIT, BUT THE SUPPLY FOR THE CONTROLLER CIRCUIT WAS ONLY 1V WHICH IS INSUFFICIENT TO RUN THE CONTROLLER. MANUFACTURING RECORDS WERE REVIEWED FOR IRREGULARITIES, AND A REVIEW OF THE RESPECTIVE BATCH RECORDS DID NOT SHOW ANY EVIDENCE OF A NON-CONFORMANCE DURING THE MANUFACTURING PROCESS. THE INVESTIGATION REVEALED THAT THE SUPERVISOR BOARD WAS DEFECTIVE. A DEFECTIVE PART GENERATED A SHORT CIRCUIT, RESULTING IN INSUFFICIENT SUPPLY VOLTAGE FOR THE CONTROLLER. BASED ON THE AVAILABLE INFORMATION AND INVESTIGATION OF THE RETURNED SAMPLE, THE RISK MITIGATION FOR THIS SITUATION WAS SUCCESSFULLY ACTIVATED. THE FAILED SUPERVISOR BOARD WAS DETECTED (COMMUNICATED BY THE BEEPING SOUND) AND THE PUMP DRIVE AUTOMATICALLY TRANSITIONED TO EMERGENCY MODE, AS DESCRIBED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TOUCH PANEL ON A NOVALUNG EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CONSOLE LOST ITS FUNCTIONALITY DURING A PATIENT¿S ECMO SUPPORT. FOLLOWING THIS EVENT, THE ECMO SUPPORT DEVICE WAS EXCHANGED WITH A MAQUET ROTAFLOW (NOT A FRESENIUS/ XENIOS PRODUCT). IT WAS STATED THE PATIENT WAS INITIALLY IN POOR CONDITION AND THEY FINALLY PASSED AWAY AFTER THE ECMO DEVICE WAS EXCHANGED (DATE OF PATIENT'S DEATH NOT REPORTED). UPON REVIEW OF AN EMAIL RESPONSE FROM THE HOSPITAL, IT WAS REPORTED THIS PATIENT WAS HOSPITALIZED FOLLOWING A MOTOR VEHICLE ACCIDENT RESULTING IN TRAUMA (EXACT DATE OF ACCIDENT AND HOSPITAL ADMISSION NOT REPORTED). THE PATIENT WAS PLACED ON ECMO SUPPORT FOR ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS). DURING ECMO SUPPORT, IT WAS NOTED THE CONTROL PANEL ON THE NOVALUNG CONSOLE BECAME INOPERABLE (EXACT DATE AND DAY ON ECMO NOT REPORTED) AND THE EMERGENCY PUMP DRIVE WAS UTILIZED TO SUSTAIN ECMO SUPPORT. PHOTOS AND A VIDEO OF THE EVENT PROVIDED BY THE HOSPITAL SHOWED UNRESOLVED ¿TECHNICAL FAILURE, OPERATOR PANEL¿, ¿PUMP DRIVE IN EMERGENCY MODE¿ AND ¿AIR BUBBLES DETECTED¿ ALARMS ON THE NOVALUNG CONSOLE DISPLAY. THE CAUSE OF DEATH WAS NOT REPORTED; HOWEVER, IT WAS STATED THE PATIENT¿S DEATH WAS RELATED TO THE NOVALUNG CONSOLE SUPPORT. NO FURTHER DETAILS WERE PROVIDED AND THERE WAS NO INDICATION THAT THE SAMPLE WAS AVAILABLE FOR PHYSICAL EVALUATION.

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL INVESTIGATION: A TEMPORAL RELATIONSHIP DOES NOT EXIST BETWEEN ECMO SUPPORT UTILIZING THE NOVALUNG CONSOLE AND THE PATIENT¿S DEATH AS IT WAS REPORTED THE ECMO DEVICE WAS EXCHANGED WITH A MAQUET ROTAFLOW PRIOR TO THEIR DEATH. IN THE ABSENCE OF A CONFIRMED CAUSE OF DEATH, RELATIONSHIP TO THE INOPERABLE NOVALUNG CONSOLE, ECMO DEVICE EXCHANGE AND AMOUNT OF TIME THE PATIENT WAS SUPPORTED BY THE MAQUET ROTAFLOW, A CAUSAL RELATIONSHIP TO THIS EVENT CANNOT BE DETERMINED. IT HAS BEEN WELL ESTABLISHED THE USE OF EMERGENCY ECMO SUPPORT FOR POST-TRAUMA PATIENT¿S CARRIES A HIGH RISK OF HEMORRHAGE THROUGH THE COURSE NORMAL COURSE OF ECMO SUPPORT. ADDITIONALLY, POST-TRAUMA PATIENTS WHO ARE SUPPORTED BY ECMO CARRY A HIGH RISK OF MORTALITY. DUE TO THE LIMITED INFORMATION AND NO CONFIRMED CAUSED OF DEATH, THE NOVALUNG CONSOLE CANNOT BE EXCLUDED AS A POTENTIAL SOURCE OR CONTRIBUTOR TO THIS ADVERSE EVENT. BASED ON THE AVAILABLE INFORMATION, AN UNSPECIFIED ALLEGATION EXISTS FROM THE FOLLOW UP STATING THE PATIENT¿S DEATH WAS RELATED TO THE NOVALUNG CONSOLE SUPPORT; HOWEVER, THERE IS NO OBJECTIVE EVIDENCE ANY FRESENIUS/ XENIOS PRODUCT(S) OR DEVICE(S) DEFICIENCY OR MALFUNCTION CAUSED OR CONTRIBUTED TO THIS PATIENT¿S ADVERSE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE RELATED TO ANY FRESENIUS DEVICE(S) AND/OR PRODUCT(S).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH PANEL ON A NOVALUNG EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CONSOLE LOST ITS FUNCTIONALITY DURING A PATIENT¿S ECMO SUPPORT. FOLLOWING THIS EVENT, THE ECMO SUPPORT DEVICE WAS EXCHANGED WITH A MAQUET ROTAFLOW (NOT A FRESENIUS/ XENIOS PRODUCT). IT WAS STATED THE PATIENT WAS INITIALLY IN POOR CONDITION AND THEY FINALLY PASSED AWAY AFTER THE ECMO DEVICE WAS EXCHANGED (DATE OF PATIENT'S DEATH NOT REPORTED). UPON REVIEW OF AN EMAIL RESPONSE FROM THE HOSPITAL, IT WAS REPORTED THIS PATIENT WAS HOSPITALIZED FOLLOWING A MOTOR VEHICLE ACCIDENT RESULTING IN TRAUMA (EXACT DATE OF ACCIDENT AND HOSPITAL ADMISSION NOT REPORTED). THE PATIENT WAS PLACED ON ECMO SUPPORT FOR ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS). DURING ECMO SUPPORT, IT WAS NOTED THE CONTROL PANEL ON THE NOVALUNG CONSOLE BECAME INOPERABLE (EXACT DATE AND DAY ON ECMO NOT REPORTED) AND THE EMERGENCY PUMP DRIVE WAS UTILIZED TO SUSTAIN ECMO SUPPORT. PHOTOS AND A VIDEO OF THE EVENT PROVIDED BY THE HOSPITAL SHOWED UNRESOLVED ¿TECHNICAL FAILURE, OPERATOR PANEL¿, ¿PUMP DRIVE IN EMERGENCY MODE¿ AND ¿AIR BUBBLES DETECTED¿ ALARMS ON THE NOVALUNG CONSOLE DISPLAY. THE CAUSE OF DEATH WAS NOT REPORTED; HOWEVER, IT WAS STATED THE PATIENT¿S DEATH WAS RELATED TO THE NOVALUNG CONSOLE SUPPORT. NO FURTHER DETAILS WERE PROVIDED AND THERE WAS NO INDICATION THAT THE SAMPLE WAS AVAILABLE FOR PHYSICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382694 NOVALUNG CONSOLE (LINUX BOARD) QJZ QJZ XENIOS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Death