BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVALUNG CONSOLE (LINUX BOARD)

    MDR report key: 11996934 · Received June 14, 2021

    Report

    Report Number
    3012172416-2021-00020
    Event Type
    Death
    Date Received
    June 14, 2021
    Date of Event
    May 8, 2021
    Report Date
    June 28, 2021
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR A MANUFACTURER EVALUATION. NO ANOMALIES OR DEVIATIONS WERE IDENTIFIED DURING REVIEW OF THE MANUFACTURING RECORDS. THE LOG DATA FROM (B)(6) 2021, 16:45 THROUGH (B)(6) 2021, 13:07 WAS REVIEWED. THE LOG DATA FOUND THAT THE STARTUP PROCESS WENT SMOOTHLY WITHOUT ANY ERROR MESSAGES OCCURRING. THERE WERE NO ABNORMALITIES DURING PRIMING MODE, THE CALIBRATION OF THE FLOW SENSOR WAS REGULAR, AND THE START WIZARD WAS COMPLETED PROPERLY. THE PATIENT WAS CONNECTED ON (B)(6) 2021 AT 18:00. THERE WAS NO EVIDENCE OF EXCESSIVE TEMPERATURE IN THE PUMP DRIVE. THE POWER CONSUMPTION WAS WITHIN ITS USUAL PARAMETERS. IN THE FOLLOWING DAYS UNTIL (B)(6) 2021 THERE WERE NO ABNORMALITIES CONCERNING THE TEMPERATURE OR POWER CONSUMPTION IN THE PUMP DRIVE. ON (B)(6) 2021, THERE WAS A SUDDEN, MASSIVE INCREASE IN THE POWER CONSUMPTION IN THE PUMP DRIVE FROM 22.43 W TO 49.35 W. THIS SUDDEN INCREASE SUGGESTS A THROMBUS FROM THE VASCULAR SYSTEM ASPIRATED VIA THE CANNULA. AS IT PROGRESSED, THE POWER CONSUMPTION IN THE PUMP DRIVE INCREASED ALONG WITH THE TEMPERATURE IN THE PUMP DRIVE, WHICH EVENTUALLY LED TO THE ALARM MESSAGE ¿PUMPDRIVE, TEMPERATURE HIGH¿ BY THE CONSOLE. THIS ALARM MESSAGE OCCURS WHEN THE TEMPERATURE EXCEEDS 75°C. THE DRIVE THEN CONTINUED TO RUN WITH A HIGH-POWER CONSUMPTION. MOST LIKELY, THE CAUSE OF THE POWER INCREASE WAS AN ASPIRATED CLOT FROM THE DRAINAGE CANNULA. THE AVAILABLE INFORMATION DOES NOT INDICATE THAT A PRODUCT FAILURE OR MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY USING THE NOVALUNG CONSOLE WITH THE XLUNG KIT OXYGENATOR HAD A MASSIVE THROMBUS THAT OBSTRUCTED THE VENOUS LINE, RESULTING IN A ¿DRIVE OVERHEATING¿ ALARM MESSAGE ON THE CONSOLE. THERE WAS NO SPECIFIC ALLEGATION THIS ADVERSE EVENT WAS DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS/ XENIOS PRODUCT(S) OR DEVICE(S). UPON REVIEW OF THE INFORMATION PROVIDED AT INTAKE, IT WAS REPORTED BY A HOSPITAL PHYSICIAN THAT SUPPORT STAFF NOTED A ¿DRIVE OVERHEATING¿ ALARM MESSAGE ON THE NOVALUNG CONSOLE ON (B)(6) 2021. THIS CRITICALLY ILL PATIENT DIAGNOSED WITH A COVID-19 INFECTION WAS ON DAY 18 OF ECMO SUPPORT IN THE INTENSIVE CARE UNIT (ICU). SUPPORT STAFF ATTEMPTED TO CHANGE THE PUMP HEAD; HOWEVER, THE PUMP HEAD COULD NOT BE REPLACED DUE TO A FAILED SELF-TEST ON THE CONSOLE. AN ADDITIONAL ATTEMPT WAS MADE TO REPLACE THE PUMP HEAD WITH PERSISTING FAILURE OF THE CONSOLE SELF-TEST. DURING THIS EVENT, A MASSIVE THROMBUS WAS NOTED IN THE VENOUS LINE THAT PREVENTED BLOOD FLOW FROM THE PATIENT AND DIRECTLY ATTRIBUTED TO THE FAILURE OF THE CONSOLE SELF-TEST. IT WAS DETERMINED THE PATIENT COULD NOT BE CONVENTIONALLY VENTILATED AS AN ALTERNATIVE DUE TO THE PATIENT¿S INCREASINGLY CRITICAL CONDITION. BEFORE ECMO SUPPORT COULD BE REINITIATED, THE PATIENT EXPIRED. THE PATIENT¿S CAUSE OF DEATH WAS NOT REPORTED. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE THE PATIENT¿S IDENTITY, FURTHER DETAILS CONCERNING THIS EVENT AND ANY RELATIONSHIP TO THE PERFORMANCE OF ANY ECMO PRODUCT(S); HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED.

    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 EXISTS BETWEEN ECMO SUPPORT UTILIZING THE NOVALUNG CONSOLE WITH THE XLUNG KIT OXYGENATOR AND THE OVERHEATING PUMP DRIVE THAT PREVENTED THE CONTINUITY OF ECMO SUPPORT. IT IS WELL ESTABLISHED ECMO IS INVASIVE LIFE SUPPORT THAT CARRIES A HIGH RISK OF MECHANICAL AND PHYSIOLOGICAL COMPLICATIONS INCLUDING HIGH PROBABILITY OF THROMBI IN THE ENVIRONMENT OF A COVID-19 INFECTION. THIS EVENT CAN BE DIRECTLY ATTRIBUTED TO THE MASSIVE THROMBUS IN THE VENOUS LINE THAT PREVENTED BLOOD FLOW AND CONSOLE SELF-TEST. A TEMPORAL RELATIONSHIP MORE THAN LIKELY DOES NOT EXIST BETWEEN THE PATIENT¿S DEATH AND ECMO SUPPORT. IT WAS STATED, DUE TO THE PATIENT¿S MASSIVE THROMBUS OCCLUDING THE VENOUS LINE, BLOOD FLOW WAS STOPPED AND ATTEMPTS TO SELF-TEST WERE CONDUCTED. THESE ACTIONS ARE EVIDENCE THE PATIENT WAS NOT ACTIVELY SUPPORTED WITH ECMO AT THE TIME OF DEATH, YET THIS CANNOT BE CONFIRMED. PATIENTS ON ECMO HAVE A HIGHER RISK FOR MORTALITY AS IT IS TYPICALLY THE MOST CRITICALLY ILL PATIENTS THAT ARE PROVIDED THIS SUPPORT AS A FINAL LIFE-SAVING EFFORT. DESPITE THESE FINDINGS, IN THE ABSENCE OF A REPORTED CAUSE OF DEATH, THE NOVALUNG CONSOLE AND XLUNG KIT CANNOT BE EXCLUDED AS A POTENTIAL CONTRIBUTOR TO THIS ADVERSE EVENT. BASED ON THE AVAILABLE INFORMATION, THERE WAS NO ALLEGATION OR OBJECTIVE EVIDENCE ANY FRESENIUS PRODUCT(S) OR DEVICE(S) DEFICIENCY OR MALFUNCTION CAUSED OR CONTRIBUTED TO THIS PATIENT¿S ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY USING THE NOVALUNG CONSOLE WITH THE XLUNG KIT OXYGENATOR HAD A MASSIVE THROMBUS THAT OBSTRUCTED THE VENOUS LINE, RESULTING IN A ¿DRIVE OVERHEATING¿ ALARM MESSAGE ON THE CONSOLE. THERE WAS NO SPECIFIC ALLEGATION THIS ADVERSE EVENT WAS DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS/ XENIOS PRODUCT(S) OR DEVICE(S). UPON REVIEW OF THE INFORMATION PROVIDED AT INTAKE, IT WAS REPORTED BY A HOSPITAL PHYSICIAN THAT SUPPORT STAFF NOTED A ¿DRIVE OVERHEATING¿ ALARM MESSAGE ON THE NOVALUNG CONSOLE ON (B)(6) 2021. THIS CRITICALLY ILL PATIENT DIAGNOSED WITH A COVID-19 INFECTION WAS ON DAY 18 OF ECMO SUPPORT IN THE INTENSIVE CARE UNIT (ICU). SUPPORT STAFF ATTEMPTED TO CHANGE THE PUMP HEAD; HOWEVER, THE PUMP HEAD COULD NOT BE REPLACED DUE TO A FAILED SELF-TEST ON THE CONSOLE. AN ADDITIONAL ATTEMPT WAS MADE TO REPLACE THE PUMP HEAD WITH PERSISTING FAILURE OF THE CONSOLE SELF-TEST. DURING THIS EVENT, A MASSIVE THROMBUS WAS NOTED IN THE VENOUS LINE THAT PREVENTED BLOOD FLOW FROM THE PATIENT AND DIRECTLY ATTRIBUTED TO THE FAILURE OF THE CONSOLE SELF-TEST. IT WAS DETERMINED THE PATIENT COULD NOT BE CONVENTIONALLY VENTILATED AS AN ALTERNATIVE DUE TO THE PATIENT¿S INCREASINGLY CRITICAL CONDITION. BEFORE ECMO SUPPORT COULD BE REINITIATED, THE PATIENT EXPIRED. THE PATIENT¿S CAUSE OF DEATH WAS NOT REPORTED. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE THE PATIENT¿S IDENTITY, FURTHER DETAILS CONCERNING THIS EVENT AND ANY RELATIONSHIP TO THE PERFORMANCE OF ANY ECMO PRODUCT(S); HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892699 NOVALUNG CONSOLE (LINUX BOARD) QJZ QJZ XENIOS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Death XLUNG KIT 230| XLUNG KIT 230| XLUNG KIT 230.