BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1804340 · Received August 11, 2010

    Report

    Report Number
    3004531588-2010-00029
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 12, 2010
    Report Date
    August 11, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NURSE HEARD A LEAKING NOISE FROM THE INOMAX DS DEVICE HEAD AND NOTIFIED A RESPIRATORY THERAPIST. THE 'LOW NITRIC OXIDE (NO) PRESSURE' ALARMED FROM THE DEVICE. THE PT'S OXYGEN SATURATION DECREASED FROM 100% TO 70%. THE INOMAX DS UNIT WAS SUBSEQUENTLY SWITCHED WITH ANOTHER DEVICE. EVAL SUMMARY: THE INVESTIGATION OF THE DEVICE IS COMPLETE AND IS AS FOLLOWS: THE DEVICE WAS CONFIRMED TO HAVE A LEAK THAT WAS TRACED TO THE PRESSURE SWITCH. THE PRESSURE SWITCH WAS REPLACED AND IT WAS CONFIRMED THE LEAK STOPPED AND WAS CORRECTED. THE ROOT CAUSE OF THE INCIDENT WAS A FAILED PRESSURE SWITCH.

    Description of Event or Problem · 1

    A (B)(6), FEMALE, WAS BORN 25 WEEKS GESTATION ON (B)(6) 2010 WITH A BIRTH WEIGHT OF (B)(6). SHE HAS A PAST MEDICAL HISTORY OR RESPIRATORY DISTRESS SYNDROME, HYALINE MEMBRANE DISEASE, METABOLIC ACIDOSIS, TREATMENT WITH SURFACTANT AND EPINEPHRINE AT BIRTH AND FRACTION OF INSPIRED OXYGEN (FIO2) 25-30%. ON (B)(6) 2010 AT 2:00, THE PT WAS STARTED ON 20 PARTS PER MILLION (PPM) OF INOMAX FOR THE TREATMENT OF BRONCHOPULMONARY DYSPLASIA AND RESPIRATORY DISTRESS SYNDROME. INOMAX WAS DELIVERED VIA INOMAX DS AND A SENSORMEDICS 3100A VENTILATOR USED IN HIGH FREQUENCY MODE WAS USED WITH THE FOLLOWING SETTINGS: FRACTION OF INSPIRED OXYGEN (FIO2) 25%, AMPLITUDE 25 CM H20, FREQUENCY 12 HERTZ, AND MEAN AIRWAY PRESSURE (MAP) 10 CM H20. ON (B)(6) 2010, AT 09:10, 7 HOURS AFTER INOMAX WAS INITIATED, THE NURSE HEARD A LEAKING NOISE FROM THE INOMAX DS DEVICE HEAD AND NOTIFIED A RESPIRATORY THERAPIST. THE 'LOW NITRIC OXIDE (NO) PRESSURE' ALARMED FROM THE DEVICE. THE PT'S OXYGEN SATURATION DECREASED FROM 100% TO 70%. THE INOMAX DS UNIT WAS SUBSEQUENTLY SWITCHED WITH ANOTHER DEVICE. DURING THE SWITCH WHICH TOOK APPROXIMATELY 10 MINUTES, THE PT'S INSPIRED OXYGEN WAS INCREASED FROM 25% TO 100% AND SHE WAS NOT MANUALLY BAGGED WITH NITRIC OXIDE. THE PT'S OXYGEN SATURATION DECREASE LASTED 4 MINUTES. AFTER THE PT WAS PLACED ON REPLACEMENT INOMAX DS UNIT, THE RESPIRATORY THERAPIST WEANED THE PT TO ROOM AIR (FIO2 21%). THE OXYGEN SATURATION DECREASE RESOLVED AND THE RESPIRATORY THERAPIST DEEMS THE OXYGEN SATURATION DECREASE SERIOUS, MODERATE IN SEVERITY AND PROBABLY RELATED TO THE DEVICE AND INTERRUPTION IN TREATMENT DURING DEVICE SWITCH.

    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 7 DA Other