BEUDAMED
    FDA Adverse Event Other Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 2281765 · Received September 29, 2011

    Report

    Report Number
    3004531588-2011-00039
    Event Type
    Other
    Date Received
    September 29, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 29, 2011
    Manufacturer
    INO THERAPEUTICS LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, A RESPIRATORY THERAPIST REPORTED TO IKARIA CUSTOMER CARE ((B)(4)) THAT ON (B)(6) 2011 INOMAX DSIR (B)(4) WENT INTO DELIVERY FAILURE TWICE WHILE ON A PT. EVALUATION SUMMARY: ON INVESTIGATION, WE WERE UNABLE TO DUPLICATE THE REPORTED OBSERVATIONS. THE INOMAX DSIR PERFORMED FULLY TO SPECIFICATIONS ON RECEIPT AND DURING EXTENDED FUNCTIONAL TESTING. BASED ON ANALYSIS OF THE INOMAX DSIR SERVICE LOG, IT WAS DETERMINED THAT VENTILATOR PEAK FLOWS MEASURED BY THE INJECTOR MODULE EXCEEDED THE MAXIMUM SPECIFICATIONS LIMITS FOR THE INOMAX DSIR DEVICE WHILE THE DEVICE WAS REPORTING A "LOW NO/N2" (NITRIC OXIDE/NITROGEN) ALARM, TO WHICH THE USER DID NOT RESPOND. THIS RESULTED IN UNDER-DELIVERY OF NITRIC OXIDE, WHICH WAS DETECTED BY THE DELIVERY MICROPROCESSOR RATIO-METRIC CALCULATION WHICH ACTIVATED AN UNDER-DELIVERY ALARM, PER DESIGN. THE FAILURE TO RESPOND TO THE LOW NO/N2 PRESSURE ALARM ENABLED THE SITUATION. SINCE PEAK AND AVERAGE INSPIRATORY FLOWS WERE VARIABLE, BUT CONSISTENTLY HIGH, AS REFLECTED IN THE SERVICE LOG, THIS INDICATES THE VENTILATOR CIRCUIT MAY HAVE DEVELOPED A LEAK OR VENTILATOR SETTINGS RESULTED IN VERY HIGH PEAK FLOWS. THE ROOT CAUSES ARE USE OF THE INOMAX DSIR OUTSIDE OF ITS SPECIFICATION LIMITS AND USER ERROR IN NOT RESPONDING APPROPRIATELY TO A DEVICE ALARM CONDITION.

    Description of Event or Problem · 1

    ON (B)(4) 2011, A RESPIRATORY THERAPIST REPORTED THAT ON (B)(6) 2011, INOMAX DSIR (B)(4) WENT INTO DELIVERY FAILURE TWICE WHILE ON A PT. WHEN THE DEVICE WENT INTO DELIVERY FAILURE THE SECOND TIME, DURING THE EVENING OF (B)(6) 2011, THE PT'S PULMONARY ARTERY PRESSURE (PAP) ROSE TO BETWEEN 110-120 MMHG FROM HIS BASELINE IN THE MID 80'S. AN ADULT MALE PT, WHO WAS NOTED TO HAVE A HISTORY OF LUNG AND CORONARY ARTERY DISEASE, WAS BEING MONITORED IN THE CARDIAC INTENSIVE CARE UNIT FOLLOWING BYPASS SURGERY (DATE OF SURGERY NOT PROVIDED). HE WAS FOUND TO HAVE PULMONARY HYPERTENSION AND WAS INITIALLY TREATED WITH FLOLAN (EPOPROSTENOL SODIUM), AND ON (B)(6) 2011, WAS SWITCHED TO TREATMENT WITH INOMAX AT 70 PPM DELIVERED VIA INOMAX DSIR (B)(4). THE PT WAS ON A SERVO I VENTILATOR (PVRC, TIDAL VOLUME: 400-450, RATE: 12, PEEP 4 OR 5, O2=60%). DURING THE DAY, ON (B)(6) 2011, THE DEVICE MONITORED DELIVERY FAILURE, AND THE RESPIRATORY THERAPIST WAS ABLE TO TROUBLESHOOT THE DEVICE AND SUCCESSFULLY RESUME DELIVERY WITHOUT IMPACT TO THE PT. DURING THE EVENING OF (B)(6) 2011, THE DEVICE AGAIN WENT INTO DELIVERY FAILURE AND IT WAS NOTED THAT THE PT'S PULMONARY ARTERY PRESS (PAP) ROSE TO BETWEEN 110-120 MMHG FROM HIS BASE LINE IN THE MID 80'S. THE RESPIRATORY THERAPIST ON DUTY ATTEMPTED TO DELIVERY NITRIC OXIDE TO THE SUBJECT VIA THE INOBLENDER, BUT HE "BELIEVED THAT THE PT WAS NOT RECEIVING ANY NITRIC THROUGH THE BLENDER", AS THE PT'S PULMONARY ARTERY PRESSURE REMAINED ELEVATED. THE PT WAS SWITCHED TO ANOTHER DEVICE AND WHEN NORMAL DELIVERY OF NITRIC OXIDE RESUMED AT 70 PPM THE PT'S PAP CAME DOWN TO BASELINE. THE RESPIRATORY THERAPIST ESTIMATED THAT THE PT'S PULMONARY ARTERY PRESSURE REMAINED ELEVATED FOR APPROXIMATELY 7-10 MINUTES, WHILE THE DEVICE WAS BEING SWITCHED OUT. THE RESPIRATORY THERAPIST DEEMED THE PT'S PULMONARY ARTERY PRESSURE INCREASE TO BE PROBABLY RELATED TO THE INTERRUPTION OF INOMAX THERAPY DUE TO THE DEVICE DELIVERY FAILURE. THE DEVICE WAS REMOVED FROM SERVICE BY THE CUSTOMER AND RETURNED TO IKARIA FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOMAX DSIR (DELIVERY SYSTEM) APARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS LLC/IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening