BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOMAX DSIR

    MDR report key: 4150997 · Received September 22, 2014

    Report

    Report Number
    4150997
    Event Type
    Death
    Date Received
    September 22, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 22, 2014
    Manufacturer
    INO THERAPEUTICS LLC/DBA IKARIA
    Product Code
    MRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE CALLED ASKED THE RESPIRATORY THERAPIST TO EXCHANGE CO2 MONITOR BECAUSE IT HAD STOPPED READING. DURING THAT TIME PATIENT'S HEART RATE (HR) DECREASED TO THE 60S-80S FROM THE 120S. THE RESPIRATORY THERAPIST ACKNOWLEDGED THE NITRIC OXIDE MACHINE WAS NOT DELIVERING THE NITRIC OXIDE. THE INO ALARMED FOR "INO DELIVERY FAILURE" AND SHOWED A RED X OVER THE DOSAGE DIAL. DURING THAT TIME PATIENT HR DECREASED TO THE 60S-80S FROM THE 120S. THE RESPIRATORY THERAPIST ACKNOWLEDGED THE NITRIC OXIDE MACHINE WAS NOT DELIVERING THE NITRIC OXIDE. RESPIRATORY THERAPIST CONTACTED SUPERVISOR AND SWITCHED THE PATIENT OVER TO MANUAL BAGGING THROUGH THE INO. ASSISTANCE WITH BAGGING AND THE INO UNIT TURNED OFF AND BACK ON TO LOW CAL, LOW CALIBRATION COMPLETED. PATIENT ARRESTED AND EXPIRED SHORTLY AFTER THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587801 INOMAX DSIR APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS LLC/DBA IKARIA INOVENT DSR *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death YES SERVO VENT