BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1666436 · Received April 22, 2010

    Report

    Report Number
    3004531588-2010-00006
    Event Type
    Death
    Date Received
    April 22, 2010
    Date of Event
    March 22, 2010
    Report Date
    April 22, 2010
    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

    NITRIC OXIDE (NO) SET AT 80 PARTS PER MILLION (PPM) READING 50 PPM. EVALUATION SUMMARY: THE DEVICE INVESTIGATION SUMMARY IS AS FOLLOWS. THE ALARM LOGS REVEALED INSTANCES OF DEVICE FAILURE FOR UNDER-DELIVERY AND HIGH NITRIC OXIDE (NO) MONITORED. IN RESPECT TO THE UNDER-DELIVERY ALARMS, THE MONITORED INJECTOR FLOW WAS REACHING PEAKS OF 120 L/MIN WITH SETPOINTS OF 80 PARTS PER MILLION (PPM) OF NO WHICH CONFLICTS WITH THE DESIGN SPECIFICATION OF 40 PPM DOSING ALLOWABLE AT 120 L/MIN. THE ROOT CAUSE FOR THIS INCIDENT WAS USER ERROR AS THE UNDER-DELIVERY APPEARS TO BE RELATED TO THE OPERATION OF THE DEVICE EXCEEDING DESIGN SPECIFICATION. THE ERROR LOG NO COUNTS IN THE OVER-DELIVERY INSTANCES ARE CONSISTENT WITH NO CELL SATURATION WHICH IS CONSISTENT WITH THE HIGH SET NO. THE INVESTIGATION ON THIS CASE IS CLOSED WITH THE FOLLOWING RATIONALE: THE STAFF IS INFORMED OF THE TECHNICAL ISSUES EXPERIENCED IN THIS CASE WITH REFERENCE TO THE OPERATING MANUAL.

    Description of Event or Problem · 1

    A (B) (6) MALE HAS A HISTORY OF PULMONARY HYPERTENSION, DECREASED PERFUSION, FLUID OVERLOAD, AND RESPIRATORY DISTRESS. ON (B) (6) 2010, HE RECEIVED 80 PARTS PER MILLION (PPM) OF INOMAX FOR THE TREATMENT OF PULMONARY HYPERTENSION. HE WAS AN UNSTABLE PATIENT. ON (B) (6) 2010, INOMAX (B) (4) WAS SET AT 80 PPM NITRIC OXIDE (NO) BUT WAS READING 50 PPM. THE RESPIRATORY THERAPIST (RT) CALLED (B) (4) TECHNICAL SUPPORT TO TROUBLESHOOT THE ISSUE. THE RT SUBSEQUENTLY REPLACED THE INJECTOR MODULE BUT THE DEVICE CONTINUED TO READ 50 PPM WHILE SET AT 80 PPM. THE RT WAS STILL TROUBLESHOOTING WITH TECHNICAL SUPPORT WHEN THE PATIENT'S OXYGEN SATURATION DECREASED TO THE 70S. THE PATIENT WAS MANUALLY BAGGED WITH 80 PPM WITH THE INOBLENDER AND THE DEVICE WAS REPLACED WITH INOMAX (B) (4). IN LESS THAN 10 MINUTES, THE PATIENT'S OXYGEN SATURATION RETURNED TO THE HIGH 80S TO 90S. THE EVENT RESOLVED AND THE RT DEEMS THE OXYGEN SATURATION DECREASE NON-SERIOUS AND MODERATE IN SEVERITY. LATER IN THE EVENING, THE NO READING FLUCTUATED FROM 54 PPM TO 70 PPM. THE PATIENT'S OXYGEN SATURATION RANGED IN THE 70S AND COULD NOT STAY IN THE 80S TO 90S. HIS BLOOD PRESSURE WAS LOW AND PERFUSION INSUFFICIENT THAT THE RT RETRIEVED THE PATIENT'S PULSE OXIMETRY FROM HIS EAR. THE PATIENT CODED SEVERAL TIMES IN THE EVENING AND AGAIN AT 23:33, AT WHICH TIME THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED, BUT THE RT DEEMED THE DEATH UNRELATED TO INOMAX.

    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 79 YR Death