INOMAX DS (DELIVERY SYSTEM)

Description of Event or Problem

BATTERY FAILURE WITH DEVICE SHUT DOWN [DEVICE BATTERY ISSUE]. NEAR RESPIRATORY ARREST [ACUTE RESPIRATORY FAILURE]. BRADYCARDIA [BRADYCARDIA]. INCREASE IN PULMONARY ARTERY PRESSURE [PULMONARY ARTERIAL PRESSURE INCREASED]. HYPOTENSION [HYPOTENSION]. CASE DESCRIPTION: THIS INITIAL SERIOUS SPONTANEOUS CASE REPORT WAS RECEIVED ON (B)(6) 2013 FROM A RESPIRATORY THERAPIST IN THE UNITED STATES REPORTING A "BATTERY FAILURE AND DEVICE SHUT DOWN WITH THE INOMAX DSIR (B)(4) WHILE ON A PT RESULTING IN THE NEED FOR INTUBATION". FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2014 IS INCLUDED IN THIS REPORT. RELEVANT MEDICAL HISTORY/CO-MORBIDITIES: (B)(6) FEMALE PT WITH SEVERE PULMONARY HYPERTENSION. RELEVANT CONCOMITANT MEDICATIONS: INTRAVENOUS FLOLAN. INOMAX WAS ADMINISTERED TO AN ADULT PT BY THE INOMAX DSIP (B)(4) AT 20 PARTS PER MILLION (PPM) VIA HIGH FLOW (35 L/MIN OXYGEN) NASAL CANNULA FOR SEVERE PULMONARY HYPERTENSION. THE START DATE INOMAX WAS 2-3 DAYS PRIOR TO THE DEVICE ISSUE WHICH OCCURRED ON (B)(6) 2013. THE RT REPORTED THE PT WAS RESPONDING WELL TO INO THERAPY. ON (B)(6) 2013, THE INOMAX DSIR ALARMED BATTERY FAILURE AND THE DEVICE WENT INTO DELIVERY FAILURE. WITHIN 10 - 15 SECONDS AFTER THE DELIVERY FAILURE THE PT BECAME BRADYCARDIAC, HYPOTENSIVE, PULMONARY ARTERY PRESSURES (PAP) INCREASED WITH A "NEAR RESPIRATORY ARREST". ACCORDING TO THE RT THE PT REQUIRED IMMEDIATE INTUBATION AND RESUSCITATIVE MEASURES INCLUDING VASOPRESSORS AND/OR INOTROPIC MEDICATIONS (NOS). AFTER INTUBATION, THE PT WAS MANUALLY VENTILATED ON 100% OXYGEN AND INOMAX VIA THE INOBLENDER AND STABILIZED QUICKLY. THE PT WAS VENTILATED WITH THE INOBLENDER FOR ABOUT 15 MINUTES WHILE THE PURITAN BENNETT 840 VENTILATOR AND BACK UP INOMAX DSIR (SERIAL NUMBER NOT PROVIDED) WERE SET UP. THE PT REMAINED STABLE ONCE CONNECTED TO THE VENTILATOR AND INOMAX DSIR. THE RT COULD NOT PROVIDE BASELINE HEART RATE, BLOOD PRESSURE OR PAP PRESSURES OR VALUES DURING DEVICE ISSUE. THE INOMAX DSIR (B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO (B)(6) FOR INSPECTION. THE RT REPORTED TO (B)(6) THAT THE BATTERY FAILURE AND DEVICE SHUT DOWN "MAY HAVE BEEN USER ERROR ON OUR PART BECAUSE THE ELECTRICAL OUTLET MAY HAVE HAD A SHORT IN IT AND WAS NOT CHARGING THE BATTERY; THIS WAS FOUND WHEN ANOTHER DEVICE WAS PLUGGED INTO THE OUTLET". THE RT CONSIDERS THE EVENTS OF BRADYCARDIA AND INCREASE IN PAP AS LIFE THREATENING DUE TO THE NEED FOR IMMEDIATE INTUBATION. THE RT DID NOT ASSESS OR PROVIDE ADDITIONAL INFORMATION ABOUT THE EVENTS OF HYPOTENSION AND NEAR RESPIRATORY ARREST.

Additional Manufacturer Narrative

(B)(4). INOMAX DSIR (B)(4) IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF COMPLETION OF INVESTIGATION.