BEUDAMED
    FDA Adverse Event Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 2971905 · Received February 19, 2013

    Report

    Report Number
    3004531588-2013-00003
    Date Received
    February 19, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 21, 2013
    Manufacturer
    IKARIA
    Product Code
    MRP
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 A RESPIRATORY THERAPIST (RT) IN (B)(6) CONTACTED IKARIA TECHNICAL SUPPORT SERVICES TO DISCUSS WHY INOMAX DSIR DEVICE # (B)(4) MEASURED NITRIC OXIDE (NO) LEVEL WAS READING LESS THAN THE SET NO VALUE WHILE IN USE WITH A BUNNELL JET VENTILATOR ((B)(4)). COMPANY COMMENT DATED (B)(4) 2013: BECAUSE THE PATIENT REQUIRED SIGNIFICANT INTERVENTION (FI02 TO 100%) TO AVOID A SERIOUS DESATURATION, THE INCREASED CONSUMPTION IS CONSIDERED SERIOUS.

    Description of Event or Problem · 1

    MONITORED NO LOWER THAN SET NO [DEVICE ISSUE]. OXYGEN REQUIREMENTS INCREASED AS MEASURED NO VALUES DRIFTED LOWER [OXYGEN CONSUMPTION INCREASED]. CASE DESCRIPTION: THIS INITIAL SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A RESPIRATORY THERAPIST (RT) IN (B)(6). THE RT CALLED TO DISCUSS WHY THE INOMAX DSIR MEASURED NITRIC OXIDE (NO) LEVEL WAS READING LESS THAN THE SET NO VALUE WHILE IN USE WITH A BUNNELL JET VENTILATOR. ADDITIONAL INFORMATION WAS OBTAINED ON (B)(4) 2013. RELEVANT MEDICAL HISTORY/COMORBIDITIES INCLUDED: MALE (B)(6). INOMAX THERAPY WAS STARTED AT 20 PARTS PER MISSION (PPM) VIA THE INOMAX DSIR (B)(4) (DEVICE INVOLVED IN THIS REPORT). THE INFANT WAS ON THE BUNNELL JET VENTILATOR WITH A FIO2 OF 40-50%. BASELINE OXYGEN SATURATION LEVELS AFTER INOMAX INITIATION WERE IN THE HIGH 80% TIO LOW 90% RANGE. ON (B)(6) 2013 AN RT NOTICED THAT WHEN THE NO DOSE WAS SET AT 20 PPM, THE MONITORED NO READING ON THE INOMAX DSIR WAS DRIFTING DOWNWARD FROM 20 PPM TO 16 PPM TO 12 PPM AND 8.5 PPM. IN ORDER TO KEEP THE PATIENT'S OXYGEN SATURATION LEVELS AT BASELINE (HIGH 80'S TO LOW 90'S) THE FIO2 ON THE JET VENT WAS INCREASED. BY 22:00 THE JET VENT SETTINGS WERE PEAK INSPIRATORY PRESSURE (PIP) 40, POSITIVE END-EXPIRATORY PRESSURE (PEEP) 13, INSPIRATORY TIME (IT) 0.02, FIO2 80-100%, RESPIRATORY RATE (RR) 360, SERVO PRESSURE 2.5 TO 2.9 AND CONVENTIONAL VENTILATOR SET TO CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) 13. THE INOMAX DSIR WAS SET AT 20 PPM AND THE MONITORED NO READING WAS 6 PPM. THE RT SPOKE WITH BOTH (B)(6) TO TRY TO IDENTIFY THE PROBLEM. THE SERVO PRESSURE WAS 2.9-4, ABOVE THE RECOMMENDED LOW SERVO PRESSURE LIMIT FOR THE BUNNELL JET VENTILATOR WHEN IN USE WITH THE INOMAX DSIR, HOWEVER, THE NO MEASURED READINGS STILL DRIFTED DOWNWARD. THE RT CHECKED ALL OF THE CONNECTIONS ON THE INOMAX DSIR AND JET VENT, BUT DID NOT CHANGE THE JET VENT OR JET CIRCUITRY BECAUSE IT APPEARED TO BE WORKING APPROPRIATELY. THE RT WANTED TO RULE OUT AN INOMAX DSIR DEVICE PROBLEM, SO SHE SWITCHED OUT DEVICE (B)(4). THE INFANT WAS MANUALLY VENTILATED WITH THE INOBLENDER AT 20 PPM AND 100% OXYGEN WHILE (B)(4) WAS SET UP. AT THAT POINT, THE PATIENT'S OXYGEN SATURATION WAS AT BASELINE (HIGH 80'S LOW 90'S). SHORTLY AFTER BEING CONNECTED TO THE SECOND INOMAX DSIR (B)(4) WITH SET NO OF 20 PPM, THE MONITORED NO STARTED TO DRIFT DOWNWARD. AT 23:00 THE PATIENT WAS SWITCHED FROM THE JET VENT TO CONVENTIONAL VENTILATION DRAGER BABYLOG 8000 ASSIST/CONTROL. WITH THE SET DOSE AT 20 PPM, THE MONITORED VALUE WAS 20 PPM, AND WITHIN 2 HOURS THE PATIENT'S FIO2 WAS REDUCED BACK TO 40%. ON (B)(6) 2013, A CHEST X-RAY SHOWED ATELECTASIS, AND THE PATIENT WAS SWITCHED BACK TO THE JET VENTILATOR (SETTINGS OF HERTZ 360 BPM, PEEP 13, I TIME, 0.02M DELTA P 25, FIO2 100%). THE INOMAX DSIR (B)(4) WAS CONNECTED AND WITHIN A FEW MINUTES OF SWITCHING BACK TO THE JET, THE NO READINGS STARTED TO DRIFT DOWN FROM 20 PPM TO 14 PPM. THE INOMAX DSIR WAS CHECKED AND REPORTEDLY FUNCTIONED CORRECTLY. A DECISION WAS MADE BY THE NEONATOLOGIST TO TREAT THE PATIENT CLINICALLY BY TITRATING THE DELIVERY OF NO TO PATIENT RESPONSE RATHER THAN USING MONITORED NO SINCE INOMAX DSIR DEVICE APPEARED TO BE DELIVERING LESS THAN SET. WITH TIGHT ALARM SETTINGS, THE SET NO WAS AT 25 PPM TO KEEP MONITORED NO 19-20 PPM. THE PATIENT WAS ALSO STARTED ON STEROIDS. INOMAX DSR (B)(4) (DEVICE INVOLVED IN THIS DEVICE REPORT) IS BEING RETURNED TO IKARIA FOR INSPECTION AND ONCE INOMAX DSIR (B)(4) (SEE 3004531588-2013-00004) IS REMOVED FROM THE PATIENT, THAT DEVICE WILL ALSO BE RETURNED TO IKARIA FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72464 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRP IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1 18 DA Other