BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOVENT, NITRIC OXIDE DELIVERY SYSTEM

    MDR report key: 11220320 · Received January 23, 2021

    Report

    Report Number
    3004531588-2021-00006
    Event Type
    Injury
    Date Received
    January 23, 2021
    Date of Event
    December 23, 2020
    Report Date
    January 22, 2021
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC.
    Product Code
    MRN
    PMA / PMN Number
    K000186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS BEING REPORTED AS A MDR DUE TO THE PATIENT'S POSSIBLE LIFE THREATENING OXYGEN SATURATION LEVEL OF 63%. THE INOMAX INOVENT WAS RETURNED FOR INVESTIGATION. DURING THE DEVICE INSPECTION THE ELECTRONIC SYSTEM SHUTDOWN ALARM WAS CONFIRMED IN THE DEVICE'S ALARM LOG, HOWEVER THE ALARM COULD NOT BE REPLICATED DURING TESTING. A FULL SERVICE CHECK WAS PERFORMED ON THE DEVICE AND A FAULTY FLOW CONTROLLER AND HIGH FLOW VALVE WERE FOUND. THESE FAULTY PARTS CAN CAUSE AN INTERMITTENT ELECTRONIC SYSTEM SHUTDOWN. THE FAULTY PARTS WERE REPLACED AND A FULL SERVICE CHECK WAS COMPLETED AND THE DEVICE PASSED ALL TESTING. THE ROOT CAUSE OF THE PATIENT'S OXYGEN DESATURATION APPEARS TO BE DUE TO THE ABRUPT WITHDRAWAL OF DRUG AS A RESULT OF THE ELECTRONIC SYSTEM SHUTDOWN. IN ADDITION, THE CUSTOMER DID NOT UTILIZE THE PROVIDED INOMAX INOVENT BACK-UP SYSTEM TO CONTINUE DRUG DELIVERY TO THE PATIENT DURING THE INCIDENT AS INSTRUCTED IN THE INOVENT OPERATOR'S MANUAL (ENGLISH VERSION 1605-0014-000, SECTION 6 PAGE 28) WHICH IF UTILIZED MAY HAVE MITIGATED THE INCIDENT. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, SPONTANEOUS SHUTDOWN AND OXYGEN DESATURATION. NO TRENDS WERE DETECTED FOR THESE COMPLAINT CATEGORIES. THE ASSESSMENT IS BASED ON INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED. ADVERSE EVENT TERMS: LOW OXYGEN SATURATION. (B)(4).

    Description of Event or Problem · 1

    THE COMMERCIAL BUSINESS MANAGER FOR (B)(6) REPORTED THAT A PATIENT EXPERIENCED OXYGEN DESATURATION WHILE ON THE INOMAX INOVENT. THE PATIENT'S HEALTHCARE TEAM (PATIENT'S PHYSICIAN AND RESPIRATORY TECHNICIAN) STATED THAT THE PATIENT WAS BEING TREATED FOR ACUTE RESPIRATORY DISTRESS SYNDROME ASSOCIATED WITH COVID 19. THE HEALTHCARE TEAM REPORTED THAT INOMAX WAS INITIATED FOR THE PATIENT ON (B)(6) 2020. THE HEALTHCARE TEAM STATED THAT THE PATIENT'S INITIAL NITRIC OXIDE DOSE WAS 40PPM AND THIS DOSE WAS THEN INCREASED TO 60PPM ON (B)(6) 2020. THE HEALTHCARE TEAM REPORTED THAT THE PATIENT WAS BEING VENTILATED WITH AN INBRIGHT VENTILATOR WITH THE FOLLOWING SETTINGS, PC 37, PEEP +7, RR18 AND OXYGEN AT 100%. THE HEALTHCARE TEAM STATED THAT THE PATIENT'S BASELINE OXYGEN SATURATION WAS 80%. THE HEALTHCARE TEAM REPORTED THAT THE PATIENT WAS IN "CRITICAL CONDITION" PRIOR TO THE INITIATION OF INOMAX, AND REMAINED UNSTABLE THROUGHOUT THEIR TREATMENT. THE HEALTHCARE TEAM STATED THAT AN ELECTRONIC DELIVERY SHUTDOWN ALARM OCCURRED AROUND 8AM (LOCAL (B)(6) TIME) ON (B)(6) 2020. THE HEALTHCARE TEAM REPORTED THAT THE INOMAX INOVENT WAS THEN CYCLED OFF/ON AND THE ALARM WAS RESOLVED. THE HEALTHCARE TEAM STATED THAT APPROXIMATELY THREE HOURS LATER THE INOMAX INOVENT ALARMED FOR ELECTRONIC DELIVERY SHUTDOWN AGAIN; HOWEVER, THE ALARM DID NOT RESOLVE WHEN THE DEVICE WAS CYCLED OFF/ON. THE HEALTHCARE TEAM REPORTED THAT DURING THE SECOND ELECTRONIC DELIVERY SHUTDOWN ALARM, THE PATIENT'S OXYGEN SATURATION DECREASED FROM 80% TO A LOW OF 63%. THE HEALTHCARE TEAM REPORTED THAT THEY THEN DECIDED TO SWAP OUT THE INOMAX INOVENT WITH A BACKUP INOMAX INOVENT DEVICE. THE HEALTHCARE TEAM STATED THAT THE PATIENT WAS NOT MANUALLY VENTILATED USING THE INOMAX INOVENT'S BACKUP SYSTEM AT THE TIME OF THE EVENT AND NO MEDICAL INTERVENTION WAS PROVIDED TO THE PATIENT. THE HEALTHCARE TEAM REPORTED THAT THE INOMAX INOVENT WAS REPLACED WITH A BACKUP DEVICE, AND ONCE THE PATIENT WAS RE-INITIATED AT 60PPM NITRIC OXIDE, THE PATIENT'S OXYGEN SATURATION RETURNED TO 78%. THE HEALTHCARE TEAM STATED THAT THE WHOLE EPISODE LASTED ABOUT TEN TO FIFTEEN MINUTES. THE HEALTHCARE TEAM REPORTED THAT THEY FELT THAT THE PATIENT'S OXYGEN DESATURATION WAS POSSIBLY RELATED TO THE DEVICE MALFUNCTION; HOWEVER, THEY STATED THAT THIS PATIENT HAD BEEN IN CRITICAL/UNSTABLE CONDITION PRIOR TO STARTING INOMAX AND HAD REMAINED UNSTABLE THROUGHOUT THIS TIME. THE DEVICE WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117005 INOVENT, NITRIC OXIDE DELIVERY SYSTEM INOVENT MRN MALLINCKRODT MANUFACTURING LLC. 1605-9200-000

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening