BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVALUNG CONSOLE (LINUX BOARD)

    MDR report key: 11757345 · Received April 30, 2021

    Report

    Report Number
    3012172416-2021-00011
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    April 9, 2021
    Report Date
    May 26, 2021
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A REPRESENTATIVE FROM XENIOS PERFORMED AN INVESTIGATION OF THE MANUFACTURING RECORDS. NO NON-CONFORMANCES OR DEVIATIONS WERE FOUND DURING THE REVIEW. IN ADDITION, THERE WERE NO EXISTING COMPLAINTS OR ERROR MESSAGES AGAINST THIS SERIAL NUMBER. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL REVIEW: UPON REVIEW OF THE INTAKE AND FOLLOW UP WITH THE CLINICAL SUPPORT SPECIALIST, IT WAS REPORTED ECMO SUPPORT FOR THIS PATIENT IN RESPIRATORY FAILURE DUE TO A COVID-19 INFECTION WAS TRANSITIONED FROM A ROTAFLOW ECMO DEVICE (NOT A FRESENIUS/ XENIOS PRODUCT) TO A NOVALUNG DEVICE WITH XLUNG KIT ON 09/APR/2021. FOLLOWING THE INITIATION OF THE NOVALUNG DEVICE, A HOSPITAL PERFUSIONIST INCREASED THE PUMP DRIVE TO GREATER THAN 7000 REVOLUTIONS PER MINUTE AND THE DELTASTREAM DP3 PUMP HEAD PRESENTED WITH A GRINDING NOISE AND VIBRATION. IT WAS FOUND THE PUMP HEAD WAS NOT PROPERLY SEATED IN THE PUMP DRIVE AS THE INTERLOCKING CLAMPS WERE NOT FULLY ENGAGED WITH THE CONNECTION. THE PUMP HEAD WAS RESEATED, COUPLED TO THE PUMP DRIVE, AND THE PUMP WAS RESTARTED. APPROXIMATELY 30 TO 45 MINUTES AFTER THIS EVENT, THE NOISE RETURNED TO THE PUMP HEAD AND IT WAS DECIDED TO EXCHANGE THE XLUNG KIT WITH A NEW ONE IN THE INTENSIVE CARE UNIT. DUE TO THE EXCHANGE, THE PATIENT HAD A SLIGHT DELAY IN ECMO SUPPORT AND PRESENTED WITH HYPOTENSION REQUIRING A ONE-TIME DOSE OF PHENYLEPHRINE (UNKNOWN ROUTE AND DOSE). ADDITIONALLY, THE PATIENT REQUIRED 500 ML OF ALBUMEN AND ONE UNIT OF PACKED RED BLOOD CELLS TO COMPENSATE FOR BLOOD LEFT IN THE EXCHANGED XLUNG KIT. THE PATIENT CONTINUES WITH ECMO SUPPORT DUE TO PULMONARY TISSUE DAMAGE WITHOUT FURTHER COMPLICATIONS. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION BEYOND THE NORMAL COURSE OF ECMO SUPPORT. IT WAS THE CONTENTION OF THE CLINICAL SUPPORT SPECIALIST AND HOSPITAL STAFF THIS EVENT WAS PREDICATED BY AN IMPROPER SETUP OF THE NOVALUNG CONSOLE AND THE XLUNG KIT WITH THE DELTASTREAM DP3 PUMP HEAD PRIOR TO THE INITIATION OF ECMO SUPPORT. ADDITIONALLY, IT WAS CONFIRMED THIS EVENT WAS NOT DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESNEIUS/ XENIOS PRODUCT(S) OR DEVICE(S).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY TRANSITIONED FROM A ROTAFLOW ECMO DEVICE (NOT A FRESENIUS/ XENIOS PRODUCT) TO A NOVALUNG DEVICE WITH XLUNG KIT. AT THE INITIATION OF ECMO THERAPY ON THE XENIOS PRODUCT, THE PUMP HEAD STARTED MAKING LOUD GRINDING NOISES AND MULTIPLE PARTS WERE RATTLING/VIBRATING BECAUSE THEY WERE LOOSE. THIS OCCURRED WHEN THE PERFUSIONIST INCREASED THE REVOLUTIONS PER MINUTE (RPMS) ON THE NOVALUNG DEVICE TO ABOVE 7000 RPMS. IT WAS REPORTED THAT THE PUMP DRIVE HOLDER WAS NOT FULLY TIGHTENED, THE COMPACT HOLDER (WHICH THE SENSOR BOX WAS ON) WAS OFF TO THE SIDE AND NOT FULLY TIGHTENED, AND THE OXYGEN TANK ON THE BACK WAS OFF TO THE SIDE AND SEATED INCORRECTLY. ALL OF THE LOOSE PARTS, WHICH WERE CONFIRMED TO BE SET UP INCORRECTLY, WERE CONTRIBUTING TO THE LOUD RATTLING AND VIBRATING NOISES. THE PUMP WAS TURNED OFF AND THE PARTS WERE TIGHTENED, AND SUBSEQUENTLY, THE RATTLING AND VIBRATING STOPPED. APPROXIMATELY 30-45 MINUTES LATER, WHEN THE PATIENT WAS TRANSPORTED BACK TO THE INTENSIVE CARE UNIT (ICU) ROOM FROM THE OPERATING ROOM, A HARSH GRINDING NOISE COULD STILL BE HEARD COMING FROM THE PUMP HEAD. AFTER CLOSELY INSPECTING THE SET UP, IT WAS DETERMINED THAT THE PUMP HEAD WAS NOT PROPERLY SEATED IN THE PUMP DRIVE. THE INTER-LOCKING CLAMPS WERE NOT FLUSH (OR COMPLETELY CLOSED). THE XLUNG KIT WAS EXCHANGED FOR A NEW ONE, AND TREATMENT WAS RESTARTED WITHOUT INCIDENT. THE GRINDING NOISE CEASED ONCE THE NEW TREATMENT BEGAN. THERE WAS NO SERIOUS INJURY OR ADVERSE EVENT DUE TO THE INCORRECT SET UP. THE PATIENT HAD A TRANSIENT DECREASE IN BLOOD PRESSURE WHICH REQUIRED INCREASED DOSES OF PHENYLEPHRINE (LEVOPHED) FOR APPROXIMATELY 10 MINUTES. THEY ALSO RECEIVED 1 UNIT OF PACKED RED BLOOD CELLS (RBC) AND 500 ML OF ALBUMIN. THE PATIENT WAS REPORTEDLY CONTINUING SUPPORT ON THE NOVALUNG DEVICE WITH NO FURTHER COMPLICATIONS. ALTHOUGH THEY HAD RECOVERED FROM A COVID-19 INFECTION, THEY WERE CONTINUING TO RECOVER FROM LONG TERM LUNG TISSUE DAMAGE. THE PATIENT HAS BEEN ON ECMO FOR APPROXIMATELY 36 DAYS. UPON FOLLOW-UP, IT WAS REPORTED THAT THE ISSUE WAS UNRELATED TO ANY DEFICIENCY OR MALFUNCTION OF THE NOVALUNG PUMP HEAD, DRIVER, OR DISPOSABLE KIT. THE PHYSICIAN/SURGEON, THE ECMO PROGRAM MANAGER, THE LEAD ECMO SPECIALISTS, AND SEVERAL BEDSIDE SPECIALISTS ALL AGREED THAT IT WAS CAUSED BY USE ERROR IN THE SET UP. THE DISPOSABLE XLUNG SET WAS REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION, AND PHOTOS AND VIDEOS WERE PROVIDED FOR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY TRANSITIONED FROM A ROTAFLOW ECMO DEVICE (NOT A FRESENIUS/ XENIOS PRODUCT) TO A NOVALUNG DEVICE WITH XLUNG KIT. AT THE INITIATION OF ECMO THERAPY ON THE XENIOS PRODUCT, THE PUMP HEAD STARTED MAKING LOUD GRINDING NOISES AND MULTIPLE PARTS WERE RATTLING/VIBRATING BECAUSE THEY WERE LOOSE. THIS OCCURRED WHEN THE PERFUSIONIST INCREASED THE REVOLUTIONS PER MINUTE (RPMS) ON THE NOVALUNG DEVICE TO ABOVE 7000 RPMS. IT WAS REPORTED THAT THE PUMP DRIVE HOLDER WAS NOT FULLY TIGHTENED, THE COMPACT HOLDER (WHICH THE SENSOR BOX WAS ON) WAS OFF TO THE SIDE AND NOT FULLY TIGHTENED, AND THE OXYGEN TANK ON THE BACK WAS OFF TO THE SIDE AND SEATED INCORRECTLY. ALL OF THE LOOSE PARTS, WHICH WERE CONFIRMED TO BE SET UP INCORRECTLY, WERE CONTRIBUTING TO THE LOUD RATTLING AND VIBRATING NOISES. THE PUMP WAS TURNED OFF AND THE PARTS WERE TIGHTENED, AND SUBSEQUENTLY, THE RATTLING AND VIBRATING STOPPED. APPROXIMATELY 30-45 MINUTES LATER, WHEN THE PATIENT WAS TRANSPORTED BACK TO THE INTENSIVE CARE UNIT (ICU) ROOM FROM THE OPERATING ROOM, A HARSH GRINDING NOISE COULD STILL BE HEARD COMING FROM THE PUMP HEAD. AFTER CLOSELY INSPECTING THE SET UP, IT WAS DETERMINED THAT THE PUMP HEAD WAS NOT PROPERLY SEATED IN THE PUMP DRIVE. THE INTER-LOCKING CLAMPS WERE NOT FLUSH (OR COMPLETELY CLOSED). THE XLUNG KIT WAS EXCHANGED FOR A NEW ONE, AND TREATMENT WAS RESTARTED WITHOUT INCIDENT. THE GRINDING NOISE CEASED ONCE THE NEW TREATMENT BEGAN. THERE WAS NO SERIOUS INJURY OR ADVERSE EVENT DUE TO THE INCORRECT SET UP. THE PATIENT HAD A TRANSIENT DECREASE IN BLOOD PRESSURE WHICH REQUIRED INCREASED DOSES OF PHENYLEPHRINE (LEVOPHED) FOR APPROXIMATELY 10 MINUTES. THEY ALSO RECEIVED 1 UNIT OF PACKED RED BLOOD CELLS (RBC) AND 500 ML OF ALBUMIN. THE PATIENT WAS REPORTEDLY CONTINUING SUPPORT ON THE NOVALUNG DEVICE WITH NO FURTHER COMPLICATIONS. ALTHOUGH THEY HAD RECOVERED FROM A COVID-19 INFECTION, THEY WERE CONTINUING TO RECOVER FROM LONG TERM LUNG TISSUE DAMAGE. THE PATIENT HAS BEEN ON ECMO FOR APPROXIMATELY 36 DAYS. UPON FOLLOW-UP, IT WAS REPORTED THAT THE ISSUE WAS UNRELATED TO ANY DEFICIENCY OR MALFUNCTION OF THE NOVALUNG PUMP HEAD, DRIVER, OR DISPOSABLE KIT. THE PHYSICIAN/SURGEON, THE ECMO PROGRAM MANAGER, THE LEAD ECMO SPECIALISTS, AND SEVERAL BEDSIDE SPECIALISTS ALL AGREED THAT IT WAS CAUSED BY USE ERROR IN THE SET UP. THE DISPOSABLE XLUNG SET WAS REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION, AND PHOTOS AND VIDEOS WERE PROVIDED FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649650 NOVALUNG CONSOLE (LINUX BOARD) QJZ QJZ XENIOS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention