BEUDAMED
    FDA Adverse Event Other Summary report: N

    INOMAX DS (DELIVERY SYSTEM)

    MDR report key: 1730108 · Received June 17, 2010

    Report

    Report Number
    3004531588-2010-00007
    Event Type
    Other
    Date Received
    June 17, 2010
    Date of Event
    May 13, 2010
    Report Date
    June 17, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESPIRATORY STAFF CALIBRATED THE DEVICE TWICE DAILY. TO PERFORM SUCTIONING ON THE PT, THE RESPIRATORY STAFF WOULD REMOVE THE PT OFF OF HFIV AND NITRIC OXIDE (NO) AND PUT THE BUNNELL JET VENTILATOR ON STAND-BY MODE. THE NO MONITORED READINGS WOULD FLUCTUATE WHEN THE PT WAS TAKEN OFF THE DEVICE FOR SUCTIONING. AFTER SUCTIONING, THE BUNNELL JET VENTILATOR WAS TAKEN OUT OF STAND-BY MODE AND PLACED BACK ON WITH NO. THE FLUCTUATING NO MONITORED VALUES PERSISTED AND THE RESPIRATORY STAFF SUBSEQUENTLY CHANGED THE INOMAX DS UNIT, BUNELL JET VENTILATOR, AND INOMAX CYLINDERS MULTIPLE TIMES. ON (B)(6) 2010, THE RESPIRATORY STAFF TROUBLESHOOTED WITH (B)(4) TECHNICAL SUPPORT TO HELP RESOLVE THE DEVICE ISSUE. ON INVESTIGATION, THE INCIDENT WAS DETERMINED TO BE A RESULT OF USER ERROR. DELIVERY FAILURES WITH HIGH NITRIC OXIDE (NO) LEVELS MONITORED WERE CONFIRMED IN THE DEVICE LOG DURING INVESTIGATION. OVER-DELIVERY DETECTION, ALARM AND DELIVERY SHUTDOWN IS A SYSTEM SAFETY DESIGN ELEMENT INTENDED TO PREVENT DELIVERY OF HIGHER THAN INTENDED DOSE OF NITRIC OXIDE. THE INOMAX DS DEVICE FUNCTIONED AS DESIGNED, AS WHEN THE BUNNELL HFJV WAS PUT INTO STANDBY IN ORDER TO SUCTION THE PT, AS PER INSTRUCTIONS IN LABELING, RESULTING IN AN ACCUMULATION OF NITRIC OXIDE IN THE BREATHING CIRCUIT SINCE THE INOMAX DS NO DELIVERY WAS NOT STOPPED. WHEN THE HFJV WAS TAKEN OUT OF STANDBY, THE INOMAX DS DETECTED THE HIGH NITRIC OXIDE LEVELS AND SHUT DOWN DELIVERY, PER DESIGN. (B)(4) TECHNICAL SUPPORT HAS ISSUED SPECIFIC DETAILED INSTRUCTIONS ON HOW TO PERFORM SUCTIONING WHEN THE BUNNELL HFJV IS USED AND USERS AT THE SITE WERE PROVIDED ADD'L TRAINING ON THE USE.

    Description of Event or Problem · 1

    (B)(6) IS A MALE (B)(6), WITH BIRTH WEIGHT OF (B)(6). HE WAS DELIVERED BREACH PRESENTATION TO A (B)(6) FEMALE, AND REQUIRED INTUBATION AND SURFACTANT AT DELIVERY. HIS APGAR SCORED WERE 2.6, AND 7. HE RECEIVED DOPAMINE, EPINEPHRINE, PACKED RED BLOOD CELLS, NORMAL SALINE FOR VOLUME EXPANSION, AND TOTAL PARENTAL NUTRITION DUE TO JEJUNAL ATRESIA. FROM (B)(6) 2010 TO (B)(6) 2010, HE RECEIVED 20 PPM OF INOMAX FOR THE TREATMENT OF PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN) AND RESPIRATORY DISTRESS SYNDROME VIA INOMAX DS (B)(4). THE RESPIRATORY STAFF CALIBRATED THE DEVICE TWICE DAILY AND THE PT WAS ON HIGH FREQUENCY JET VENTILATION (HFJV) WITH THE BUNNELL JET VENTILATOR AND INTERMITTENT MANDATORY VENTILATION (IMV) WITH INOMAX. THE VENTILATOR SETTINGS FOR HFJV WERE HIGH POSITIVE END-EXPIRATORY PRESSURE (PEEP) AND PEAK INSPIRATORY PRESSURE (PIP). TO PERFORM SUCTIONING ON THE PT, THE RESPIRATORY STAFF WOULD REMOVE THE PT OFF OF HFIV AND NITRIC OXIDE (NO) AND PUT THE BUNNELL JET VENTILATOR ON STAND-BY MODE. THE NO MONITORED READINGS WOULD FLUCTUATE WHEN THE PT WAS TAKEN OFF THE DEVICE FOR SUCTIONING. AFTER SUCTIONING, THE BUNNELL JET VENTILATOR WAS TAKEN OUT OF STAND-BY MODE AND PLACED BACK ON WITH NO. ON (B)(6) 2010, WHEN THE PT WAS PLACED BACK ON NO AFTER SUCTIONING WAS PERFORMED, HE IMMEDIATELY DESATURATED FROM 92% (BASELINE) TO 65% AND EXPERIENCED BRADYCARDIA AT APPROXIMATELY 50 BEATS PER MINUTE. THE OXYGEN SATURATION DECREASE LASTED FOR ONE MINUTE. THE RESPIRATORY STAFF TOOK THE PT OFF OF THE DEVICE AND MANUALLY BAGGED HIM WITH NITRIC OXIDE TO IMPROVE OXYGEN SATURATION. THE BRADYCARDIA RESOLVED AND THE PT'S OXYGEN SATURATION RETURNED TO 90%. PANCURONIUM (PAVULON) WAS GIVEN TO THE PT. THE MONITORED NO VALUES CONTINUED TO FLUCTUATE AND WOULD NOT STABILIZE, CAUSING THE RESPIRATORY STAFF TO REPLACE INOMAX DS (B)(4) WITH ANOTHER DEVICE. IT TOOK APPROXIMATELY 3 MINUTES TO SWITCH OUT THE DEVICE. THE FLUCTUATING NO MONITORED VALUES PERSISTED AND THE RESPIRATORY STAFF SUBSEQUENTLY CHANGED THE INOMAX DS UNIT, BUNNELL JET VENTILATOR, AND INOMAX CYLINDERS MULTIPLE TIMES. ON (B)(6) 2010, THE RESPIRATORY STAFF TROUBLESHOOTED WITH (B)(4) TECHNICAL SUPPORT TO HELP RESOLVE THE DEVICE ISSUE. THE RESPIRATORY THERAPIST STATES THE PT IS DOING OK. THE RESPIRATORY THERAPIST DEEMS THE EVENTS NON-SERIOUS, MODERATE IN SEVERITY, POSSIBLY RELATED TO THE DEVICE AND PROBABLY RELATED TO THE DRUG.

    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 MO Other