BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOMAX DSIR PLUS (DELIVERY SYSTEM)

    MDR report key: 19230474 · Received May 2, 2024

    Report

    Report Number
    3004531588-2024-00038
    Event Type
    Death
    Date Received
    May 2, 2024
    Date of Event
    April 2, 2024
    Report Date
    May 2, 2024
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC
    Product Code
    MRN
    UDI-DI
    00867538000106
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS USED FOR TREATMENT. THIS COMPLAINT IS REPORTABLE AS A MDR AS THE MEDICAL PROFESSIONAL STAFF COULD NOT RULE OUT THE POSSIBILITY THAT THE INOMAX DSIR PLUS DEVICE COULD HAVE CAUSED OR CONTRIBUTE TO THE PATIENT'S ADVERSE EVENTS AND DEATH. SINCE THE REPORTABLE EVENT IS ONLY ASSOCIATED WITH THIS DEVICE, THE MDR WILL ONLY BE AGAINST THIS DEVICE. THE INOMAX DSIR PLUS DEVICE WAS RETURNED FOR INVESTIGATION. THE REVIEW OF THE SERVICE LOG REVEALED REVEALED A LOW CYLINDER PRESSURE ALARM WITH A DELIVERY SETPOINT AT 40PPM AND A CALCULATED DELIVERY OF 40.23 PPM, FOLLOWED BY A LOW NO ALARM WITH A DELIVERY SETPOINT AT 40PPM AND A CALCULATED DELIVERY OF .42 PPM. THIS IS CONSISTENT WITH A LOSS OF NO PRESSURE DUE TO A NO/N2 LEAK. THE REPORTED "HISSING" SOUND EMANATING FROM THE DEVICE WAS CONFIRMED AND REVEALED THAT THE SHUTOFF VALVE HAD FAILED AND THE ENDCAP HAD BLOWN OFF. THE SHUTOFF VALVE WAS REPLACED AND THE DEVICE PASSED ALL SUBSEQUENT LEAK TESTING AND IS READY TO RETURN TO CIRCULATION FOR CUSTOMER USE. THE MOST LIKELY ROOT CAUSE FOR THE PATIENT'S HYPOTENSION, CARDIAC ARREST, AND DEATH WAS THE ABRUPT DISCONTINUATION OF NITRIC OXIDE DUE TO THE SHUTOFF VALVE FAILURE. THE HOSPITAL STAFF WAS ABLE TO UTILIZE THE INOBLENDER WHILE WAITING FOR THE BACKUP DEVICE. PER THE INOBLENDER OPERATOR'S MANUAL PAGE 4, THE INTENDED USE FOR THE INOBLENDER IS AS A BACK UP TO A PRIMARY INOMAX DELIVERY SYSTEM; OR FOR SHORT TERM ATTENDED USE WHEN A PRIMARY DELIVERY DEVICE CANNOT PRACTICABLY BE USED.THE PATIENT WAS ABLE TO RECOVER FROM CARDIAC ARREST ONCE SHE WAS PLACED ON A FUNCTIONAL BACKUP DEVICE. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES, NO / N2 SYSTEM LEAK, HYPOTENSION, CARDIAC ARREST, AND DEATH. 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: HYPOTENSION, CARDIAC ARREST, AND DEATH COMP-(B)(4). (B)(4) 02-MAY-2024.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED TO REPORT SECONDHAND THAT A INOMAX DSIR PLUS DEVICE MALFUNCTIONED WHILE IN PATIENT USE. THIS DEVICE WAS BEING UTILIZED IN CONJUNCTION WITH HAMILTON G-5 VENTILATOR WITH A SET NO DOSE OF 40PPM. THE PATIENT WAS A 75-YEAR-OLD FEMALE THAT WAS IN CRITICAL CONDITION WITH UNDERLYING MEDICAL ISSUES. THE CUSTOMER STATED THE PATIENT HAS BEEN RECEIVING INOMAX THERAPY FOR A FEW WEEKS BUT WAS UNSURE OF WHEN THE THERAPY WAS STARTED. AT THIS TIME, THE CUSTOMER WAS UNABLE TO PROVIDE THE VENTILATOR SETTINGS NOR THE PATIENT'S MEDICAL HISTORY OR MEDICATIONS. AT APPROXIMATELY 5:00 AM, THE NIGHTSHIFT RESPIRATORY THERAPIST AND A NURSE WERE IN THE PATIENT'S ROOM DOING THEIR ROUTINE PATIENT ASSESSMENT WHEN THEY HEARD A "POPPING" SOUND. THE NIGHTSHIFT RESPIRATORY THERAPIST STATED THE "POPPING" SOUND WAS FOLLOWED BY A HISSING SOUND COMING FROM BEHIND THE DEVICE. THEY STATED UPON INVESTIGATION, THEY DISCOVERED A LEAK EMANATING FROM WHERE THE REGULATOR HOSE WAS CONNECTED. THEY CONFIRMED THE REGULATOR HOSE WAS STILL CONNECTED TO THE BACK OF THE INOMAX DSIR PLUS HEAD. THE NIGHTSHIFT RESPIRATORY THERAPIST STATED THEY NOTICED THE PRESSURE ON THE REGULATOR GAUGE WAS STARTING TO DROP FROM 1600PSI. THE AMOUNT OF PRESSURE THE INOMAX CYLINDER LOST WAS UNDETERMINED. THE NIGHTSHIFT RESPIRATORY THERAPIST STATED THE LEAK PERSISTED AFTER THEY CONNECTED THE SECOND REGULATOR TO THE SECOND CYLINDER. THEY THEN DECIDED TO UTILIZE THE INOMAX DSIR PLUS DEVICE'S INOBLENDER AND MANUALLY VENTILATE THE PATIENT WHILE A BACKUP INOMAX DSIR PLUS DEVICE WAS BEING PREPARED. AT THIS TIME, THE PATIENT'S BLOOD PRESSURE STARTED TO DECREASE. THE CUSTOMER STATED THE PATIENT THEN WENT INTO CARDIAC ARREST AND WHILE THEY WERE MANUALLY RESUSCITATING, THEY BEGAN PERFORMING CHEST COMPRESSIONS. THIS OCCURRED AT APPROXIMATELY 05:06 AM. THE CUSTOMER WAS UNABLE TO PROVIDE THE PATIENT'S VITAL SIGNS AS THEY WERE NOT PRESENT AT THE TIME OF THE EVENT. THE CUSTOMER STATED THE PATIENT RECOVERED FROM CARDIAC ARREST ONCE PLACED ON A FUNCTIONAL INOMAX DSIR PLUS BACKUP DEVICE. THE CUSTOMER DID NOT KNOW HOW LONG THE PATIENT WAS UNDER CARDIAC ARREST. NO FURTHER ISSUES OCCURRED WITH THE SECOND DEVICE DURING INOMAX THERAPY. THE CUSTOMER STATED THE PATIENT EVENTUALLY EXPIRED. THE CUSTOMER STATED THAT THE SECOND DEVICE WAS REMOVED FROM THE PATIENT'S ROOM AND IS NOW ON STANDBY FOR PATIENT USE AS THERE WERE NO ISSUES/MALFUNCTIONS WITH THIS DEVICE WHILE THE PATIENT WAS RECEIVING INOMAX THERAPY. THE INOMAX DSIR PLUS DEVICE WAS RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857401 INOMAX DSIR PLUS (DELIVERY SYSTEM) NITRIC OXIDE ADMINISTRATION APPARATUS MRN MALLINCKRODT MANUFACTURING LLC 10007 00867538000106

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death| R| L