BEUDAMED
    FDA Adverse Event Other Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 2364360 · Received December 6, 2011

    Report

    Report Number
    3004531588-2011-00046
    Event Type
    Other
    Date Received
    December 6, 2011
    Date of Event
    November 11, 2011
    Report Date
    December 6, 2011
    Manufacturer
    INO THERAPEUTICS LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RESPIRATORY THERAPIST REPORTED A DELIVERY FAILURE ALARM ON INOMAX DS DEVICE #(B)(4), AND THE PT'S SPO2 DROPPED TO 79%. THE RT STARTED TO MANUALLY VENTILATE THE PT VIA AN INOBLENDER SET AT 50 PPM NO AND 100% O2 FLOW. (B)(4). EVAL SUMMARY: UPON RETURN OF THE DEVICE TO A SERVICE CENTER FOR INVESTIGATION, THE SERVICE LOG WAS EXAMINED. A LOG ENTRY SHOWED THAT A HIGH NITRIC OXIDE SENSOR CALIBRATOR WAS ATTEMPTED WHILE THE SAMPLE LINE WAS STILL CONNECTED TO THE VENTILATOR CIRCUIT, RATHER THAN TO THE CALIBRATION GAS, AS IS INDICATED IN LABELING. THIS CAUSE ERRONEOUS FACTORS TO BE LOADED INTO DEVICE SOFTWARE. THE MONITORED NITRIC OXIDE LEVEL WAS THEN ERRONEOUSLY CALCULATED TO BE GREATER THAN 100 PPM, CAUSING THE DEVICE TO ALARM AND GO INTO DELIVERY FAILURE, AS DESIGNED. THE ROOT CAUSE FOR THE INCIDENT WAS USER ERROR IN NOT FOLLOWING INSTRUCTIONS FOR CALIBRATING THE NITRIC OXIDE SENSOR, AS CONTAINED IN DEVICE LABELING.

    Description of Event or Problem · 1

    THIS INITIAL SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM A RESPIRATORY THERAPIST (RT) IN THE (B)(4) REGARDING A MALE ADULT PT WHO EXPERIENCED OXYGEN SATURATION DECREASED AND DELIVERY FAILURE ALARM, WHILE ON INOMAX DS. MEDICAL HISTORY INCLUDED PT ON INOMAX DS SET AS 43 PPM (PARTS PER MILLION) NITRIC OXIDE, FIO2 100% VIA PB 840 VENTILATOR WITH A BASELINE OF SPO2 OF 90%. THE PT WAS ON A ROTO-REST BED (USED FOR SHORTENING VENTILATOR DEPENDENCY AND TO PREVENT PNEUMONIA). THE RT REPORTED THE NURSE HAD HEARD THE LOW SPO2 ALARM AND CALLED HIM. ANOTHER RT SAW THE DELIVERY FAILURE ALARM AND THE SPO2 WAS 79%, AT WHICH TIME HE STARTED TO MANUALLY VENTILATE THE PT WITH THE INOBLENDER SET AT 50 PPM NITRIC OXIDE AND 100% OXYGEN FLOW. THE RPTR CAME IN TO ASSIST AND CYCLED THE INOMAX DS OFF AND ON IN AN ATTEMPT TO RESET THE DELIVERY FAILURE, BUT IT WOULD NOT CLEAR. THE RPTR WAS NOT SURE WHAT THE MONITORED NITRIC OXIDE VALUE WAS AT THIS TIME. AFTER 5 MINUTES OF MANUAL VENTILATION THE PT RETURNED TO SPO2 OF 90%. THE RPTR SWITCHED THE INOMAX DS AND THE PT WAS REESTABLISHED ON THE VENTILATOR AND THE REPLACEMENT INOMAX DS WITH A NITRIC OXIDE SET AT 43 PPM. THE DEVICE WAS SENT FOR SERVICE EVALUATION. ADDITIONAL INFO WAS REQUESTED, BUT AFTER MULTIPLE ATTEMPTS VIA PHONE, WAS NOT SUCCESSFUL.

    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 Other