BEUDAMED
    FDA Adverse Event Other Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 2249654 · Received August 31, 2011

    Report

    Report Number
    3004531588-2011-00036
    Event Type
    Other
    Date Received
    August 31, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 31, 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
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, A RESPIRATORY THERAPIST (RT) REPORTED DELIVERY FAILURE THAT OCCURRED ON (B)(6) 2011 WITH TWO INOMAX DS UNITS, (B)(4) (MDR# 3004531588-2011-00037) AND (B)(4). DURING INVESTIGATION, THE REPORTED DEVICE FAILURE COULD NOT BE REPORTED. EXAMINATION OF THE INOMAX DS SERVICE LOG SHOWED THAT THE DEVICE'S BACKUP DELIVERY MODE WAS TURNED ON WHILE THE DEVICE WAS DELIVERING DRUG BY NORMAL MODE. THIS RESULTED IN A MONITORED DRUG CONCENTRATION IN EXCESS OF 100PPM, TRIGGERING A DELIVERY FAILURE, AS DESIGNED. CONTRIBUTING TO THE DELIVERY FAILURE WAS INTERRUPTION OF VENTILATION, WHILE NOT PLACING THE VENTILATOR INTO STANDBY, WHICH WOULD ALSO RESULT IN A HIGH DRUG CONCENTRATION IN THE DELIVERY CIRCUIT. THE ROOT CAUSE FOR THIS INCIDENT WAS USER ERROR.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A RESPIRATORY THERAPIST (RT) REPORTED DELIVERY FAILURE THAT OCCURRED ON (B)(6) 2011 WITH TWO INOMAX DS UNITS, (B)(4) AND (B)(4). A FULL TERM NEWBORN WITH MECONIUM ASPIRATION WAS ON INOMAX THERAPY AT 20 PARTS PER MILLION (PPM) VIA THE INOMAX DS ((B)(4)) FOR APPROX ONE WEEK WITH GOOD RESULTS. THE NEWBORN WAS ON THE BUNNELL JET VENTILATOR WITH FRACTIONAL INSPIRED OXYGEN (FIO2) OF 100%, PEAK INSPIRATORY PRESSURE (PIP) 39 CM H2O, FREQUENCY 360, POSITIVE END EXPIRATORY PRESSURE (PEEP) 7 CM H2O. ON (B)(6) 2011, THE PT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED TO SUCTION (UNABLE TO DETERMINE IF THE INOBLENDER WAS UTILIZED FOR MANUAL VENTILATION). ACCORDING TO THE RESPIRATORY THERAPIST, THE JET WAS NOT PUT INTO STANDBY MODE. WHEN THE JET VENTILATOR FLOW WAS RESTARTED THE DELIVERY FAILURE ALARM ON THE FIRST INOMAX DS ((B)(4)) APPEARED. THE FIRST INOMAX DS WAS POWERED DOWN TO CORRECT THE DELIVERY FAILURE AND WHEN POWERED UP THE DELIVERY FAILURE DISPLAYED FOR A SECOND TIME. THE RT STATED THE JET VENTILATOR FLOW HAD NOT BEEN RESTARTED WHEN THE INOMAX DS WAS POWERED UP. THE BEDSIDE CLINICIANS THEN PROCEEDED TO CHANGE THE INOMAX DS UNIT TO A SECOND UNIT. THE SECOND INOMAX DS ((B)(4)) UNIT PASSED THE PRE-USE PROCEDURE. THE RT REPORTED THAT THE SECOND INOMAX DS WAS SET UP IN THE JET CIRCUIT AND THE FLOW THROUGH JET CIRCUIT HAD NOT YET BEEN RESTARTED WHEN A DELIVERY FAILURE APPEARED ON THE SECOND DEVICE AS WELL. THE BEDSIDE CLINICIAN NOTED THE MONITORED NO WAS GREATER THAN 100 PPM NO (EXACT VALUE NOT KNOWN). DURING THIS TIME, THE PT EXPERIENCED HEMODYNAMIC CHANGES AND OXYGEN DESATURATION (PARAMETERS NOT PROVIDED). A F/U PHONE CALL TO THE TREATING PHYSICIAN REVEALED THE PT EXPERIENCED HEMODYNAMIC CHANGES AND OXYGEN DESATURATION DUE TO A PNEUMOTHORAX. SINCE THEY WERE UNABLE TO PROPERLY OXYGENATE THE INFANT DUE TO THE PNEUMOTHORAX, A DECISION WAS MADE TO START THE INFANT ON ECMO. THE PHYSICIAN STATED THAT THE SWITCH FROM INO THERAPY TO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS PROBABLY NOT RELATED TO THE DEVICE FAILURE OR DRUG INOMAX AND WAS PROBABLY DUE TO THE INFANT'S DETERIORATING CONDITION POST PNEUMOTHORAX. THE DEVICE WAS TAKEN OUT OF SERVICE AND RETURNED TO IKARIA FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOMAX DS (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS LLC/IKARIA 10003

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening