BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1920132 · Received December 8, 2010

    Report

    Report Number
    3004531588-2010-00135
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 9, 2010
    Report Date
    December 8, 2010
    Manufacturer
    INO THERAPEUTICS, LLC/IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, A RESPIRATORY THERAPIST (RT) REPORTED THAT THE INJECTOR MODULE TUBING GOT INADVERTENTLY KNOCKED OFF OF INOMAX DS DEVICE # (B)(4). THE DEVICE WAS SUBSEQUENTLY RECONNECTED BY THE RT WITHIN 30 SECONDS. SHORTLY AFTER THE TUBING WAS RECONNECTED, AN 'X' APPEARED IN THE DOSE AREA OF THE SCREEN AND THE DELIVERY FAILURE ALARM ACTIVATED. THE CIRCUMSTANCES LEADING TO THE EVENT WERE DISCUSSED, AND THE ISSUE RESOLVED, BY TELEPHONE WITH (B)(6). DEVICE REMAINED IN SERVICE. EVALUATION SUMMARY: (B)(6) WAS ABLE TO DETERMINE THE CAUSE FOR THE INCIDENT BY TELEPHONE, WITH NO NEED TO RETURN THE DEVICE FOR SERVICE VALUATION. THE DEVICE WAS FOUND TO HAVE NO FAULT AND OPERATED TO SPECIFICATION. THIS WAS CONFIRMED BY BOTH (B)(6) AND THE END USER. THE ROOT CAUSE OF THE DEVICE FAILURE WAS USER ERROR AS THE INJECTOR MODULE TUBING WAS INADVERTENTLY KNOCKED OFF OF INOMAX DS DEVICE. THE INOMAX DS FUNCTIONED AS DESIGNED BY ALARMING.

    Description of Event or Problem · 1

    A (B)(6) FEMALE INFANT BORN ON (B)(6) 2010 WAS PLACED ON INOMAX THERAPY WITH THE INOMAX DS ON (B)(6) 2010 IN CONJUNCTION WITH THE BUNNELL JET VENTILATOR. INFANT'S BASELINE OXYGEN SATURATION LEVELS WERE AROUND 90% ON A FRACTIONAL INSPIRED OXYGEN (FI02) OF 40 TO 50%. AROUND 1900 ON (B)(6) 2010, A RESPIRATORY THERAPIST (RT) REPORTED THAT THE INJECTOR MODULE TUBING GOT KNOCKED OFF THE DEVICE ACCIDENTALLY AND WAS RECONNECTED BY RT WITHIN 30 SECONDS. SHORTLY AFTER THE TUBING WAS RECONNECTED, AN X APPEARED IN THE DOSE AREA OF THE SCREEN AND THE DELIVERY FAILURE ALARM WENT OFF. THE RT CHECKED THE DEVICE, CHANGED THE SAMPLE LINE, TURNED THE DEVICE OFF, THEN BACK ON AS PER INSTRUCTION MANUAL BUT THE DELIVERY FAILURE ALARM REMAINED ON. IT APPEARED THAT THE DEVICE WAS STILL DELIVERING NITRIC OXIDE AT 20 PARTS PER MILLION AS PRESCRIBED. TROUBLESHOOTING THE DEVICE TOOK APPROXIMATELY 10 MINUTES. DURING THAT TIME, THE INFANT REMAINED STABLE WITH OXYGEN SATURATION LEVELS AROUND 90%. SINCE THE INOMAX DS WAS STILL READING DELIVERY FAILURE, RESPIRATORY THERAPY SET UP A NEW INOMAX DS DEVICE AND SWITCHED OUT THE DEVICES. DURING THE TIME RESPIRATORY THERAPY WAS TROUBLESHOOTING AND SETTING UP THE NEW DEVICE, THE NURSING STAFF WAS WORKING WITH THE BABY, CHANGING THE INFANT'S DIAPER AND REPOSITIONING HER. AFTER THE DEVICE WAS SUCCESSFUL SWITCHED OUT FOR A NEW DEVICE, THE INFANT BEGAN TO DESATURATE FROM HER BASELINE OF 90% TO THE 60-70% RANGE FOR A FEW MINUTES. THE FIO2 WAS INCREASED TO 100%. THE INFANT'S OXYGEN SATURATION LEVEL IMMEDIATELY BEGAN TO RISE AND ONCE THE INFANT'S OXYGEN SATURATION LEVEL RETURNED TO BASELINE, THE FIO2 WAS WEANED BACK TO THE 40-50% RANGE AND THE EVENT RESOLVED. THE RESPIRATORY THERAPIST DEEMS THE EVENT OF OXYGEN DESATURATION AS MODERATE IN SEVERITY AND POSSIBLE RELATED TO DEVICE FAILURE AND 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 1 DA Other