BEUDAMED
    FDA Adverse Event Other Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 3240810 · Received July 17, 2013

    Report

    Report Number
    3004531588-2013-00016
    Event Type
    Other
    Date Received
    July 17, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 A RESPIRATORY THERAPIST (RT) IN THE UNITED STATES SPOKE WITH IKARIA TECHNICAL SUPPORT REGARDING A DELIVERY FAILURE THAT OCCURRED WITH INOMAX DSIR ((B)(4)) WHILE IN USE ON A PATIENT. ((B)(4)). EVALUATION SUMMARY: THE INOMAX DSIR DEVICE WAS RETURNED TO THE MANUFACTURER FOR SERVICE INVESTIGATION. REVIEW OF THE SERVICE LOG REVEALED THAT THE DEVICE DELIVERY FAILURE WAS CAUSED BY A MEASURED NO READING GREATER THAN THE MAXIMUM ALLOWABLE NO READING OF 100 PPM. THE LOG ALSO REVEALED THAT SHORTLY BEFORE THE DELIVERY FAILURE, THE BREATHING CIRCUIT FLOW THROUGH THE INJECTOR MODULE (IM) HAD PEAKED AT OR ABOVE THE MAXIMUM SPECIFIED IM FLOW OF 120 LITERS PER MINUTE (IPM) AND THEN QUICKLY DECREASED BACK TO THE AVERAGE IM FLOW OF 4 IPM. THIS SUDDEN INCREASE AND DECREASE IN THE IM FLOW IS THE MOST LIKELY CAUSE OF THE MEASURED NO READING EXCEEDING 100 PPM. THE LOG WAS THEN EXAMINED FOR EVIDENCE OF ANY FACTOR THAT COULD HAVE CAUSED OR CONTRIBUTED TO A PEAK IM FLOW AT OR ABOVE 120 IPM. A CAUSE COULD NOT BE DETERMINED DEFINITIVELY ALTHOUGH IT IS POSSIBLE THAT THE VENTILATOR CIRCUIT MAY HAVE BEEN MOMENTARILY OPENED, CONTRIBUTING TO THE HIGH FLOW RATE. A FULL FUNCTIONAL TEST OF THE DEVICE WAS THEN PERFORMED. THE DEVICE PASSED ALL TESTS IN ACCORDANCE WITH SPECIFICATIONS AND WAS RETURNED TO THE DEVICE POOL FOR DISTRIBUTION. THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED AS THE DEVICE PERFORMED WITHIN SPECIFICATIONS WHEN FUNCTIONALLY TESTED AT THE REGIONAL SERVICE CENTER. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER IKARIA'S QUALITY SYSTEM. IT SHOULD BE NOTED THAT AT THE TIME OF THE DELIVERY FAILURE OF THE INOMAX DSIR, THE RT DID NOT INITIATE USE OF THE INOBLENDER BACKUP DEVICE AS INDICATED IN THE DEVICE LABELING. THIS BACKUP DEVICE IS INTENDED TO HELP PREVENT THIS TYPE OF INCIDENT IN THE EVENT OF FAILURE OF THE PRIMARY DELIVERY DEVICE.

    Description of Event or Problem · 1

    DSIR WENT INTO DELIVERY FAILURE [DEVICE ISSUE]. INOBLENDER NOT USED [DEVICE MISUSE]. PT EXPERIENCED AN OXYGEN DESATURATION [OXYGEN SATURATION DECREASED]. CASE DESCRIPTION: THIS INITIAL SERIOUS SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A RESPIRATORY THERAPIST (RT) IN THE UNITED STATES VIA IKARIA CUSTOMER CARE. THE RT, A SECOND HAND REPORTER, CALLED TO SPEAK WITH IKARIA TECHNICAL SUPPORT REGARDING A DELIVERY FAILURE WITH A DSIR AND AN ASSOCIATED OXYGEN DESATURATION. THE PT WAS A FULL TERM MALE (B)(6) TRANSPORTED FROM ANOTHER HOSPITAL BECAUSE OF CARDIAC ISSUES, NOT OTHERWISE SPECIFIED (NOS). HE WAS INTUBATED AND ON CONVENTIONAL VENTILATION WITH THE FOLLOWING SETTINGS: SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION (SIMV), RATE 30 BREATHS PER MINUTE, PEAK INSPIRATORY PRESSURE (PIP) 25 CM H2O PRESSURE, POSITIVE END-EXPIRATORY PRESSURE (PEEP) 7 CM H2O PRESSURE, PRESSURE SUPPORT 10, FRACTION OF INSPIRED OXYGEN CONCENTRATION (FIO2) 100%. THE (B)(6) WAS STARTED ON INOMAX VIA THE INOMAX DSIR ((B)(4)) AT 20 PARTS PER MILLION ON (B)(6) 2013 AT 02:00 HOURS. THE PT'S BASELINE OXYGEN SATURATION ON THOSE SETTINGS WAS 92%. A LITTLE BEFORE 04:00 ON (B)(6) 2013, THE INOMAX DSIR WENT INTO DELIVERY FAILURE. THE REPORTER STATED THAT WHEN THE DELIVERY FAILURE OCCURRED, THE BEDSIDE RT CHECKED FOR LEAKS, PERFORMED A LOW RANGE CALIBRATION AND REPLACED THE INOMAX CYLINDER. THE REPORTER STATED THAT THE PATIENT WAS NOT BEING BAGGED AT THAT TIME. THE BEDSIDE RT WAS UNABLE TO CORRECT THE ALARM MESSAGE AND DECIDED TO PLACE THE PT ON A BACKUP DEVICE. THE RT STATED THAT WHILE SETTING UP THE BACKUP DEVICE, THE PT WAS MANUALLY VENTILATED WITH 100 PERCENT OXYGEN ONLY (INOBLENDER NOT UTILIZED), AT WHICH TIME THE PT'S O2 SATURATION LEVEL DECREASED FROM 92% TO THE LOW 80'S; THE DESATURATION LASTED ABOUT 30 MINUTES WHILE ANOTHER DSIR WAS SET UP. ACCORDING TO THE REPORTER, WHEN THE BEDSIDE RT PLACED, THE PT ON THE BACK UP DEVICE (SERIAL NUMBER NOT PROVIDED), THE DEVICE FUNCTIONED AS EXPECTED AND THE PT'S O2 SATURATION INCREASED TO 92-98 PERCENT. THE INOMAX DSIR (B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO IKARIA FOR INSPECTION. THE REPORTER STATED THAT THE EVENT OF OXYGEN DESATURATION WAS A RESULT OF THE PATIENT BEING OFF INOMAX AND BEING MANUALLY VENTILATED WITH OXYGEN ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331817 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRN IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1 19 DA Other