NOXBOXI NITRIC OXIDE DELIVERY SYSTEM

Additional Manufacturer Narrative

THE DEVICE WAS INVESTIGATED ONSITE AT THE HOSPITAL. ALL TESTING WAS CONDUCTED IN ACCORDANCE WITH ESTABLISHED SERVICE AND TEST PROCEDURES. GAS-DELIVERY ACCURACY, MONITORING PERFORMANCE, AND ALL OTHER FUNCTIONAL CHECKS WERE CONFIRMED TO BE WITHIN SPECIFICATION. REVIEW OF THE EVENT DETAILS INDICATED THAT THE PATIENT WAS A CRITICALLY ILL PREMATURE NEONATE AND EXPERIENCING SIGNIFICANT CLINICAL INSTABILITY. THE REPORTED FLUCTUATIONS WERE OBSERVED TO CORRELATE WITH EPISODES OF PATIENT AGITATION AND VENTILATOR ALARMS, AND IMPROVEMENT WAS REPORTED FOLLOWING REPOSITIONING OF THE SAMPLING LINE CLOSER TO THE PATIENT. BASED ON THE AVAILABLE INFORMATION, THE OBSERVED FLUCTUATIONS WERE DETERMINED TO BE PRIMARILY ATTRIBUTABLE TO PATIENT RELATED FACTORS PRESENT DURING TREATMENT. DOSE FLUCTUATIONS OCCURRING WHEN THE DEVICE IS USED IN CONJUNCTION WITH THE BUNNELL LIFEPULSE JET VENTILATOR ARE KNOWN TO ARISE UNDER LOW TOTAL VOLUMETRIC FLOW CONDITIONS, DEPENDING ON VENTILATOR SETTINGS AND PATIENT CHARACTERISTICS. THIS FAILURE MODE HAS BEEN PREVIOUSLY IDENTIFIED BY THE MANUFACTURER AND IS BEING ADDRESSED AS PART OF AN ONGOING FIELD CORRECTION AND REMOVAL REPORTED TO THE FDA.

Description of Event or Problem

(E1) REPORTED THAT WHILE DELIVERING INHALED NITRIC OXIDE (INO) THERAPY TO A 24-WEEK GESTATIONAL AGE NEONATAL PATIENT USING THE (D4) DEVICE, FLUCTUATIONS IN THE MONITORED NITRIC OXIDE CONCENTRATION WERE OBSERVED. THE DEVICE WAS BEING USED IN CONJUNCTION WITH A BUNNELL LIFEPULSE JET VENTILATOR (MODEL 203/204). ACCORDING TO THE HOSPITAL REPORT, THE NITRIC OXIDE DOSE WAS SET TO 20 PPM AND THE MONITORED CONCENTRATION FLUCTUATED APPROXIMATELY BETWEEN 16 PPM AND 30 PPM. THE PATIENT WAS REPORTED TO BE CLINICALLY UNSTABLE, REQUIRING 80-100% FIO2 AND EXPERIENCING FREQUENT DESATURATION EVENTS UNRELATED TO THE PERFORMANCE OF THE DEVICE. HOSPITAL STAFF PERFORMED EXTENSIVE TROUBLESHOOTING, INCLUDING REPOSITIONING THE SAMPLE LINE CLOSER TO THE PATIENT WHICH RESULTED IN AN OBSERVED IMPROVEMENT IN DOSE STABILITY. HOSPITAL CLINICIANS NOTED THAT THE FLUCTUATIONS APPEARED TO CORRELATE WITH EPISODES OF PATIENT AGITATION AND VENTILATOR ALARMS AND EXPRESSED THE OPINION THAT THE OBSERVED FLUCTUATIONS WERE LIKELY RELATED TO THE PATIENT'S CONDITION RATHER THAN A MALFUNCTION OF THE DEVICE. NO PATIENT HARM OR LASTING ADVERSE EFFECTS WERE REPORTED. VENTILATOR MODE AND SETTINGS: BUNNELL LIFEPULSE JET VENTILATOR (MODEL 203/204): PIP 39, RATE 300, I-TIME 0.26, 75% O2. SERVO PRESSURE 3.0.