BEUDAMED
    FDA Adverse Event Other Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1914365 · Received November 18, 2010

    Report

    Report Number
    3004531588-2010-00127
    Event Type
    Other
    Date Received
    November 18, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 18, 2010
    Manufacturer
    INO THERAPEUTICS LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED THAT THE NITRIC OXIDE (NO) VALUE DROPPED ON THE INOMAX DS (B)(4). THE NO GAUGE DROPPED TO 0 PPM AND THE LOW NO/N2 PRESSURE ALARMED. SHE SWAPPED OUT THE CYLINDER. ONCE THE VALVE WAS FULLY OPENED, THE DEVICE FUNCTIONED CORRECTLY. DEVICE TROUBLESHOOTING BY PHONE WITH TECHNICAL SUPPORT RESOLVED USER ERROR ISSUE. EVAL SUMMARY: TECHNICAL SUPPORT WAS ABLE TO DETERMINE THE CAUSE FOR THE INCIDENT BY TELEPHONE, WITH NO NEED TO RETURN THE DEVICE FOR SERVICE VALUATION. THE PRESSURE REGULATOR VALVE ON THE DRUG CYLINDER WAS FOUND TO BE NOT FULLY OPEN AS ADVISED IN LABELING. ISSUE WAS RESOLVED WHEN THE VALVE WAS FULLY OPENED.

    Description of Event or Problem · 1

    A (B)(6) FEMALE WITH A HISTORY OF MECONIUM SYNDROME AND PERSISTENT PULMONARY HYPERTENSION OF THE (B)(6) ((B)(6)) WAS ON A SENSORMEDICS 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR WITH A FLOW OF 20 LITERS/MINUTE, MEAN AIRWAY PRESSURE (MAP 26, HERTZ 6, 54 CM WATER PRESSURE AND FRACTION OF INSPIRED OXYGEN (FIO2) OF 100%. SHE WAS STARTED ON INOMAX AT 40 PARTS PER MILLION (PPM) ON (B)(6) 2010. ON (B)(6) 2010, A RESPIRATORY THERAPIST REPORTED THE NITRIC OXIDE (NO) VALUE DROPPED ON THE INOMAX DS DEVICE (B)(4). THE NO GAUGE DROPPED TO 0 PPM AND THE LOW NO/N2 PRESSURES ALARMED. THE (B)(6) EXPERIENCED AN OXYGEN SATURATION DECREASE FROM 96% TO 84% LASTING APPROX 2 MINS. MANUAL BACK-UP VENTILATION WITH INOMAX WAS NOT PERFORMED DURING THE EVENT. THE RESPIRATORY THERAPIST SWAPPED OUT THE CYLINDER WITH A NEW CYLINDER. AFTER SPEAKING WITH (B)(4)TECHNICAL SUPPORT, THE RESPIRATORY THERAPIST DETERMINED THAT THE FIRST CYLINDER'S VALVE WAS NOT OPENED ALL THE WAY DURING SET UP. THE RESPIRATORY THERAPIST MADE SURE THE NEW CYLINDER'S VALVE WAS FULLY OPENED AND THE DEVICE FUNCTIONED CORRECTLY WITHOUT FURTHER PROBLEMS. THE INFANT RECOVERED FROM THE EVENT WITHOUT INTERVENTION OR FURTHER INCIDENT. THE RESPIRATORY THERAPIST DEEMED THE OXYGEN SATURATION DECREASE FROM 96% TO 84% FOR APPROX 2 MINS AS A MODERATELY SEVERE, NON-SERIOUS, AND DEFINITELY RELATED TO DRUG THERAPY.

    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 16 DA