INOMAX DSIR (DELIVERY SYSTEM)

Description of Event or Problem

SAMPLING LINE / FILTER OCCLUDED [DEVICE ISSUE]. MONITORED NITRIC OXIDE ROSE TO 136 PPM AND DEVICE WENT INTO DELIVERY FAILURE AFTER SAMPLING LINE AND FILTER WERE REPLACED [DEVICE ISSUE]. CASE DESCRIPTION: ON (B)(6) 2014 A MAUDE SAFETY REPORT (B)(4) WAS RECEIVED BY IKARIA FROM THE FDA REGARDING A MEDICAL DEVICE COMPLAINT. THE REPORTER, A NURSE IN A HOSPITAL IN THE UNITED STATES, STATED THAT ON (B)(6) 2013 THERE WAS AN "EQUIPMENT FAILURE" WITH THE INOMAX DS (SERIAL NUMBER NOT PROVIDED). THE REPORT STATED "NITRIC OXIDE (NO) SAMPLING LINE/FILTER OCCLUDED THEN DISPLAY READ 'NO DELIVERY FAILURE' AFTER LINE AND FILTER REPLACED. MACHINE WAS IMMEDIATELY REPLACED WITH NO COMPLICATIONS NOTED". IT IS IMPORTANT TO NOTE THAT IN THE UNITED STATES IKARIA REPLACED ALL INOMAX DS DEVICES IN THE FIELD WITH THE INOMAX DSIR BY (B)(6) 2013, THEREFORE ALTHOUGH THE REPORTER LISTED THE DEVICE BRAND/TYPE AS INOMAX DS IT WAS THE INOMAX DSIR THAT WAS IN USE AT THE TIME OF THE EQUIPMENT FAILURE. A SEARCH OF THE IKARIA SAFETY DATABASE REVEALED NO SAFETY REPORTS FOR THE INOMAX DSIR DURING THE TIMEFRAME INDICATED ON THE MAUDE REPORT. A SEARCH OF THE IKARIA COMPLAINT DATABASE REVEALED A COMPLAINT REPORT RECEIVED ON (B)(6) 2013 FROM A HOSPITAL IN THE UNITED STATED FOR THE INOMAX DSIR (DS20100242) THAT HAD A SAMPLE LINE FILTER BLOCK. ACCORDING TO THE REPORTER, THE PATIENT WAS RECEIVING NEBULIZED MEDICATION TREATMENTS AND RT DID NOT USE A DISK FILTER. THE DISPOSABLES WERE CHANGED AND THE SAMPLE LINE FILTER BLOCK ALARM CLEARED. IMMEDIATELY FOLLOWING THAT THE MONITORED NO ROSE TO 136PPM AND A DELIVERY FAILURE ALARM APPEARED. THE SET NO WAS 30PPM. THE DELIVERY FAILURE WAS CLEARED BY REBOOTING THE DEVICE. A LOW CALIBRATION WAS DONE AND PASSED. A HIGH CALIBRATION WAS ATTEMPTED BUT INTERRUPTED BY A SAMPLE LINE FILTER BLOCK ALARM. THE DEVICE WAS SWITCHED OUT WITH ANOTHER INOMAX DSIR (SERIAL NUMBER NOT PROVIDED) AND INOMAX DSIR DS20100242 WAS REMOVED FROM SERVICE AND RETURNED TO IKARIA FOR INSPECTION. IKARIA PROVIDED DISK FILTERS TO THE SITE. ACCORDING TO THE REPORTER, THERE WAS NO IMPACT TO THE PATIENT.

Additional Manufacturer Narrative

ON (B)(6) 2014 A MAUDE SAFETY REPORT (B)(4) WAS RECEIVED BY IKARIA FROM THE FDA REGARDING A MEDICAL DEVICE COMPLAINT. THE REPORTER, A NURSE IN A HOSPITAL IN THE UNITED STATES, STATED THAT ON (B)(6) 2013 THERE WAS AN "EQUIPMENT FAILURE" WITH THE INOMAX DS (SERIAL NUMBER NOT PROVIDED). THE REPORT STATED "NITRIC OXIDE SAMPLING LINE/FILTER OCCLUDED THEN DISPLAY READ 'NO DELIVERY FAILURE' AFTER LINE AND FILTER REPLACED. MACHINE WAS IMMEDIATELY REPLACED WITH NO COMPLICATIONS NOTED". (B)(4). INVESTIGATION RESULTS COMPLETED ON (B)(4) 2013. EVALUATION SUMMARY: AS IS IKARIA'S PRACTICE, THIS MANUFACTURER'S MDR IS BEING SUBMITTED IN RESPONSE TO THE RECEIPT OF A USER MDR FROM THE FDA. A MEDWATCH FORM WAS NOT SUBMITTED AT THE TIME THE EVENT WAS ORIGINALLY REPORTED TO IKARIA BY THE HOSPITAL BECAUSE THE DEVICE ISSUE WAS NOT ASSOCIATED WITH AN ADVERSE EVENT TO A PATIENT. INOMAX DSIR DEVICE SERIAL NUMBER (B)(4) WAS RETURNED TO THE MANUFACTURER FOR SERVICE INVESTIGATION. THE CUSTOMER STATED THAT THE DEVICE DISPLAYED HIGH NO ALARM. WHILE TRYING TO PERFORM A HIGH NO CALIBRATION, DEVICE WENT INTO SAMPLE LINE/FILTER BLOCK. THE IKARIA REGIONAL SERVICE CENTER (RSC) REVIEWED THE SERVICE LOGS AND WAS ABLE TO VERIFY THAT THE REPORTED ALARMS DID OCCUR, BUT COULD NOT REPRODUCE OR VERIFY THE COMPLAINTS ON THE DEVICE ITSELF. THE RSC POWERED THE DEVICE UP IN CUSTOMER MODE AND NO ALARMS WERE PRESENT. THE SAMPLE SYSTEM WAS INSPECTED FOR ANY FORM OF CONTAMINATION AND/OR LEAKS AND NONE WERE PRESENT. THE SERVICE LOGS DOD NOT SHOW ANY SYMPTOMS OR TRENDS LEADING UP TO THE HIGH NO ALARM. THE DEVICE WAS NOT DUE FOR ANY PLANNED MAINTENANCE SERVICE AND ALL CELLS ARE WELL WITHIN EXPIRATION DATES. THE DEVICE WAS FULLY FUNCTIONAL. THE SAMPLE LINE/FILTER BLOCK ALARMS COULD NOT BE REPRODUCED AT THE RSC. IT IS LIKELY THAT THE SAMPLE LINE/FILTER BLOCK ALARM EXPERIENCED BY THE USER WAS CAUSED BY NEBULIZED MEDICATION(S) BEING ASPIRATED INTO THE SAMPLE SYSTEM. DEVICE LABELING DIRECTS THE USE OF A DISK FILTER WHEN A NEBULIZER IS USED, AND THAT THE SAMPLE LINE BE LOCATED PROXIMAL TO THE NEBULIZER. THIS TYPE OF BLOCKAGE WOULD BE RESOLVED BY THE REPLACEMENT OF THE DISPOSABLES AS DESCRIBED BY THE USER. THE CAUSE OF THE HIGH CALIBRATION FAILURE IS UNKNOWN. THE ROOT CAUSE FOR THIS INCIDENT WAS: REPORTED FAILURE NOT REPRODUCIBLE.