BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOMAX DSIR PLUS (DELIVERY SYSTEM)

    MDR report key: 17961447 · Received October 18, 2023

    Report

    Report Number
    3004531588-2023-00087
    Event Type
    Death
    Date Received
    October 18, 2023
    Date of Event
    September 18, 2023
    Report Date
    October 18, 2023
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC.
    Product Code
    MRN
    UDI-DI
    00867538000106
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS BEING REPORTED AS AN MDR DUE TO THE FACT THAT THE CUSTOMER 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. A REVIEW OF THE DEVICE'S SERVICE LOG REVEALED THAT A DELIVERY FAILURE ALARM OCCURRED DUE TO AN APPARENT INTER-PROCESSOR LINK (IPL) FAILURE BETWEEN THE DEVICE'S MONITORING PROCESSOR AND DELIVERY PROCESSOR. ALTHOUGH IDENTIFIED IN THE DEVICE'S SERVICE LOG, THE REGIONAL SERVICE CENTER (RSC) DID NOT EXPERIENCE A DELIVERY FAILURE ALARM DURING TESTING. THE ROOT CAUSE FOR THIS OCCURRENCE WAS LIKELY DUE TO A MALFUNCTIONING PCA MAIN BOARD. AS A RESULT, THE PCA MAIN BOARD WAS REPLACED OUT OF PRECAUTION. THE RSC DID NOT EXPERIENCE A HUMMING NOISE DURING TESTING AND FOUND NO CONTAMINATION IN THE SAMPLE SYSTEM. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE OPERATED ACCORDING TO SPECIFICATIONS. AS A RESULT, THE DEVICE WAS PLACED BACK INTO CIRCULATION FOR CUSTOMER USE. THE MOST LIKELY ROOT CAUSE FOR THE PATIENT'S OXYGEN DESATURATION, BRADYCARDIA, AND DEATH WAS ABRUPT DISCONTINUATION OF NITRIC OXIDE DUE TO THE DELIVERY FAILURE. HOWEVER, THE FACT THAT THE PATIENT'S NURSING STAFF WAS MANUALLY VENTILATING THE PATIENT AFTER THE DELIVERY FAILURE WITH A MANUAL RESUSCITATOR AND MASK THAT WAS NOT CONNECTED TO EITHER THE DEVICE'S INOBLENDER OR AN O2 SUPPLY COULD HAVE POSSIBLY CONTRIBUTED TO THE PATIENT'S DETERIORATING CONDITION. 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 RESPIRATORY THERAPIST WAS NOT ABLE TO FULLY UTILIZE THE INOBLENDER WHEN SHE ARRIVED IN THE PATIENT'S ROOM DUE TO THE PATIENT'S DO NOT RESUSCITATE /DO NO INTUBATE ORDER. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORIES DELIVERY FAILURE, NOISY, OXYGEN DESATURATION, BRADYCARDIA, 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: LOW OXYGEN SATURATION AND BRADYCARDIA. (B)(4). (B)(6). ON (B)(6) 2023.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED TO REPORT THAT A PATIENT PASSED AWAY WHILE RECEIVING INOMAX NITRIC OXIDE TREATMENT WITH THE INOMAX DSIR PLUS DEVICE. THE CUSTOMER STATED THAT THE PATIENT WAS A 61-YEAR-OLD MALE WHO WAS BEING TREATED WITH INOMAX NITRIC OXIDE FOR PULMONARY HYPERTENSION. THE CUSTOMER REPORTED THAT THE PATIENT WAS ON A HIGH FLOW NASAL CANNULA WITH A FIO2 OF 70%, AN INSPIRATORY FLOW RATE OF 60LPM, AND INOMAX NITRIC OXIDE AT 20PPM. THE CUSTOMER STATED THAT THE PATIENT'S BASELINE HEART RATE (HR) WAS 115 BEATS/MINUTE (BPM) AND THEIR BASELINE OXYGEN SATURATION (SPO2) WAS 98%. THE CUSTOMER REPORTED THAT THE PATIENT WAS ALSO RECEIVING THE FOLLOWING MEDICATIONS, PULMICORT, PREDNISONE, VASOPRESSIN, DOBUTAMINE AND LEVOPHED. THE CUSTOMER STATED THAT ON (B)(6) 2023 AT 13:39, THE PATIENT'S VENTILATORY SUPPORT WAS DECREASED TO A FIO2 OF 60%, AN INSPIRATORY FLOW RATE OF 40LPM, AND THE INOMAX NITIC OXIDE DOSE REMAINED AT 20PPM. THE CUSTOMER REPORTED THAT THE PATIENT APPEARED TO TOLERATE THIS REDUCTION IN VENTILATOR SUPPORT AS THEY ONLY EXHIBITED A SMALL DECREASE IN THEIR SPO2 FROM 98% TO 92%. THE CUSTOMER STATED THAT AT 14:05, THE NURSING STAFF REPORTED THAT THE PATIENT'S SON CAME OUT OF THE PATIENT'S ROOM AND INFORMED THE STAFF THAT THE INOMAX DSIR PLUS DEVICE WAS MAKING A "HUMMING NOISE" AND THAT HIS "FATHER DID NOT LOOK RIGHT". THE CUSTOMER REPORTED THAT WHEN THE NURSE ARRIVED AT THE PATIENT'S ROOM, THE NURSE HEARD THE HUMMING NOISE COMING FROM THE INOMAX DSIR PLUS DEVICE. THE CUSTOMER STATED THAT THE NURSE REPORTED THAT THE INOMAX DSIR PLUS DEVICE WAS ALARMING AND THERE WAS A RED X ON THE DEVICE'S DISPLAY. THE CUSTOMER ALSO REPORTED THAT THE PATIENT'S SPO2 HAD DROPPED TO 74% DURING THIS INCIDENT. THE CUSTOMER REPORTED THAT THE NURSING STAFF BEGAN TO TREAT THE PATIENT WITH ONE STAFF MEMBER NOTIFYING THE RESPIRATORY THERAPIST (RT) OF THE ISSUE. THE CUSTOMER STATED THAT THE RT CLAIMED THAT WHEN THEY WERE INITIALLY NOTIFIED OF THE ISSUE, THEY WERE TOLD IT WAS "OK", AND THAT THEY WERE NOT NEEDED. THE CUSTOMER REPORTED THAT THE RT STATED THAT SHORTLY AFTER THAT THEY WERE ALERTED BY AN OVERHEAD PAGE TO A "CODE BLUE" OR MEDICAL EMERGENCY IN THE PATIENT'S ROOM. THE CUSTOMER STATED THAT WHEN THE RT ARRIVED AT THE PATIENT'S ROOM, THEY DID NOT NOTICE ANY ALARMS PRESENT ON THE INOMAX DSIR PLUS DEVICE. THE CUSTOMER REPORTED THAT THE NURSING STAFF WAS ALREADY MANUALLY VENTILATING THE PATIENT WITH A MANUAL RESUSCITATOR AND MASK WHEN THE RT ARRIVED IN THE PATIENT'S ROOM. HOWEVER, THE CUSTOMER STATED THAT THE MANUAL RESUSCITATOR WAS NOT CONNECTED TO EITHER THE DEVICE'S INOBLENDER OR ANY O2 SUPPLY. THE CUSTOMER REPORTED THAT THE RT THEN NOTICED THAT PATIENT'S HEART RATE HAD DROPPED INTO THE 30BPM-40BPM RANGE AND THE PATIENT'S SPO2 HAD DROPPED INTO THE 67%-70% RANGE. THE CUSTOMER STATED THAT THE RT IMMEDIATELY CONNECTED THE MANUAL RESUSCITATOR TO THE DEVICE'S INOBLENDER AND SET A DOSE FOR 20PPM AND BEGAN TO MANUALLY VENTILATE THE PATIENT VIA THE MASK. THE CUSTOMER REPORTED THAT SHORTLY THEREAFTER, IT WAS NOTED THAT THE PATIENT HAD A DO NOT RESUSCITATE /DO NO INTUBATE ORDER AND ALL VENTILATION EFFORTS WERE STOPPED. THE CUSTOMER STATED THAT THE PATIENT PASSED AWAY AT 14:46 ON (B)(6) 2023. THE CUSTOMER REPORTED THAT AFTER THE INCIDENT THE RT ATTEMPTED TO DUPLICATE WHAT THE NURSING STAFF REPORTED SEEING AND HEARING WITH THE INOMAX DSIR PLUS DEVICE, BUT THEY COULD NOT REPLICATE THE ISSUE. THE CUSTOMER STATED THAT THE DEVICE WAS THEN PUT IN STANDBY MODE AND WHEN THEY POWERED IT UP THE NEXT DAY THERE WERE NO ALARMS PRESENT. THE CUSTOMER REPORTED THAT THE PATIENT'S PHYSICIAN COULD NOT RULE OUT THE POSSIBILITY THAT THE PATIENT MAY HAVE DEVELOPED A MUCOUS PLUG, WHICH COULD HAVE OCCLUDED THE PATIENT'S AIRWAY LEADING TO THE PATIENT'S DETERIORATION. HOWEVER, THE CUSTOMER STATED THAT DUE TO THE PATIENT'S ALREADY COMPROMISED CONDITION AND THE FACT THAT NO RT MEMBER WITNESSED THE DEVICE ISSUE, THEY COULD NOT STATE THAT THE INOMAX DSIR PLUS DEVICE WAS OR WAS NOT RESPONSIBLE FOR THE PATIENT'S WORSENING CONDITION. THE DEVICE WAS RETURNED FOR INVESTIGATION. THIS MEDWATCH IS FOR THE PATIENT'S SERIOUS ADVERSE EVENT. THE REPORTABLE MALFUNCTION IS CAPTURED IN MEDWATCH 3004531588-2023-00092.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618696 INOMAX DSIR PLUS (DELIVERY SYSTEM) NITRIC OXIDE ADMINISTRATION APPARATUS MRN MALLINCKRODT MANUFACTURING LLC. 10007 00867538000106

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death