BEUDAMED
    FDA Adverse Event Other Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 2214286 · Received July 28, 2011

    Report

    Report Number
    3004531588-2011-00031
    Event Type
    Other
    Date Received
    July 28, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 28, 2011
    Manufacturer
    INO THERAPEUTICS LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, A RESPIRATORY THERAPIST CONTACTED (B)(4) TECHNICAL SUPPORT TO REPORT THAT THE INOMAX (B)(4) WAS READING DEVICE FAILURE. THE CIRCUMSTANCES LEADING TO THE INCIDENT WERE DISCUSSED, AND THE ISSUE WAS RESOLVED, BY TELEPHONE TECHNICAL SUPPORT. DEVICE REMAINED IN SERVICE. EVALUATION SUMMARY: THE INOMAX DS DEVICE PERFORMED TO SPECIFICATIONS. DEVICE LABELING ADVISES USERS OF THE NEED TO USE A ONE-WAY VALVE WITH HIGH FREQUENCY VENTILATORS. THE ONE-WAY VALVE WAS NOT USED IN THE CIRCUIT CONFIGURATION IN THIS INSTANCE, LEADING TO A "DEVICE FAILURE" CONDITION AS THE INOMAX DS SHUT DOWN, AS DESIGNED, TO PREVENT OVER-DELIVERY OF DRUG PRODUCT. TECHNICAL SUPPORT WAS SUCCESSFUL IN TROUBLESHOOTING THE INAPPROPRIATE SETUP CONDITION OVER THE PHONE. WHEN A ONE-WAY VALVE WAS INSTALLED PER THE OPERATOR'S MANUAL, THE DEVICE FUNCTIONED AS INTENDED AND THERE WAS NO NEED TO RETURN IT FOR FURTHER INVESTIGATION. THE ROOT CAUSE FOR THIS INCIDENT WAS USER ERROR.

    Description of Event or Problem · 1

    A PREMATURE FEMALE WAS BORN AT (B)(6) GESTATION ON (B)(6) 2011, WITH A LEFT CONGENITAL DIAPHRAGMATIC HERNIA, ONE KIDNEY AND PERSISTENT PULMONARY HYPERTENSION (PPH). THE NEONATE WAS INTUBATED AND PLACED ON CONVENTIONAL VENTILATION. HER CONDITION CONTINUED TO DETERIORATE AND OVER THE NEXT SEVERAL DAYS. A DIAPHRAGMATIC HERNIA REPAIR WAS PERFORMED ON (B)(6) 2011. ON (B)(6) 2011, SHE WAS STARTED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE NEONATE WAS ON THE BUNNELL JET VENTILATOR AND SERVO I WITH FRACTION OF INSPIRED OXYGEN (FIO2) 100%. JET SETTINGS: SERVO PRESSURE 5.4, PEAK INSPIRATORY PRESSURE (PIP) 30 CM H2O, FREQUENCY 240 BREATHS PER MINUTE. SERVO I SETTINGS: PRESSURE CONTROL OF 10, POSITIVE END EXPIRATORY PRESSURE (PEEP) 8 CM H2O, RATE 8 BREATHS PER MINUTE, PRESSURE SUPPORT 8. THE OXYGEN SATURATION LEVELS WERE VERY LOW DESPITE MAXIMUM RESPIRATORY SUPPORT. ON (B)(6) 2011, INOMAX THERAPY WAS STARTED WITH THE INOMAX DS ((B)(4)) AT (B)(4) AND THE NEONATE'S OXYGEN SATURATION LEVELS CAME UP TO 78%. OVER THE NEXT 19 DAYS, THE NEONATE REMAINED CRITICALLY ILL WITH MULTIPLE EPISODES OF OXYGEN DESATURATION DUE TO THE SLIGHTEST CHANGE IN HER ENVIRONMENT. ON (B)(6) 2011, A RESPIRATORY THERAPIST CONTACTED (B)(4) TECHNICAL SUPPORT TO REPORT THAT THE INOMAX (B)(4) WAS READING DEVICE FAILURE. THE RT STATED THAT SHE WAS TOLD BY ANOTHER RT TO TURN OFF THE INOMAX DS, THEN TURN IT BACK ON TO ALLEVIATE THE PROBLEM. WHEN THIS WAS DONE, THE INFANT DESATURATED DOWN TO 50% RANGE. THE RT STATED THAT THEY HAD PROBLEMS WITH THE INOMAX DS ALARMING DEVICE FAILURE THROUGHOUT THE WEEKEND AND EACH TIME THE DEVICE ALARMED, THE INFANT DESATURATED TO THE 50% RANGE THEN SLOWLY CAME BACK UP. DURING TODAY'S DEVICE FAILURE ALARM, THE RT REMOVED THE INOMAX DS FROM THE PATIENT TO TROUBLESHOOT THE DEVICE. THE INFANT DESATURATED TO THE 50% RANGE AND REMAINED THERE FOR 20-30 MINUTES WHILE OFF INOMAX. ACCORDING TO TH RT, THE INFANT COULD NOT TOLERATE REMOVAL FROM THE JET VENTILATOR FOR MANUAL VENTILATION WITH THE INOBLENDER. THE RT AND THE RESPIRATORY THERAPY CLINICAL EDUCATOR CALLED (B)(4) TECHNICAL SUPPORT (TS) FOR ASSISTANCE. THE CUSTOMER CONFIRMED TO (B)(4) TS THAT THE DEVICE WAS SHOWING A DELIVERY FAILURE ALARM. DURING TROUBLESHOOTING WITH (B)(4) TS, IT WAS IDENTIFIED THAT THE SITE DID NOT HAVE THE ONE-WAY VALVE IN THE VENTILATOR CIRCUIT AS RECOMMENDED IN THE INOMAX DS MANUAL. THE RT STATED THAT THEY DO NOT LIKE TO USE THE ONE-WAY VALVE DUE TO A BUILDUP OF WATER IN THE VENTILATOR CIRCUIT. (B)(4) TS INFORMED THE RT THAT WITHOUT THE ONE-WAY VALVE IN PLACE, THE INJECTOR MODULE WOULD SENSE FLOW IN THREE DIRECTIONS AND THAT COULD LEAD TO A HIGH NO DELIVERY WHICH WOULD CAUSE, PER THE DESIGN OF THE DEVICE, A DELIVERY FAILURE AS THE RESULT OF A HIGH MONITORED NO VALUE. (B)(4) TS DIRECTED THE RT TO THE (B)(4) WEBSITE TO VIEW A PICTURE OF THE ONE-WAY VALVE AND ARRANGED TO HAVE (B)(4) CUSTOMER SERVICE DELIVER THE ITEM TO THE SITE. THE CUSTOMER WAS ABLE TO CONFIGURE THE VENTILATOR CIRCUIT USING A ONE WAY VALVE THEY HAD ONSITE AND REINITIATE INOMAX THERAPY. THE INFANT'S OXYGEN SATURATION LEVELS CAME UP SLOWLY TO THE 78% RANGE. AS OF THIS REPORT, THE BABY REMAINS IN CRITICAL CONDITION ON MAXIMUM LIFE SUPPORT. THE RESPIRATORY THERAPY CLINICAL EDUCATOR STATED THAT THE INOMAX DS WAS SET UP INCORRECTLY AND THAT USER ERROR IN ASSOCIATION WITH THE INFANT'S CRITICAL CONDITION CAUSED THE EPISODES OF OXYGEN DESATURATION. THE RT DEEMS THE EVENT OF OXYGEN DESATURATION AS SERIOUS AND POSSIBLY RELATED TO THE REMOVAL OF THE INFANT FROM THE INOMAX THERAPY DUE TO INCORRECT SET UP OF THE INOMAX DS DEVICE. (B)(4) CLINICAL SPECIALIST WILL CONTACT SITE TO RETRAIN ON PROPER SET UP PROCEDURE FOR INOMAX DS WITH THE BUNNELL JET VENTILATOR.

    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 1 MO Other