Description of Event or Problem · 1
PREMATURE INFANT IN NICU WAS CONNECTED TO INO MAX DSIR MEDICAL GAS DELIVERY SYSTEM WHICH CREATED AN ALARM FOR APPARENT NITRIC OXIDE SENSOR FAILURE. THE INO WAS SET AT 10 PPM AND PATIENT RECEIVED NITRIC OXIDE (NO) THROUGHOUT THE EVENT. THE NO SAMPLE LINE DISPLAY READING DROPPED; INO FILTER WAS CHANGED; NEW INO TANK CHANGED; THEN INO DELIVERY MACHINE WAS CHANGED OUT. PATIENT'S SPO2'S REMAINED STABLE THROUGHOUT THE EVENT; NO CARDIAC ISSUES. NEW INO MAX DSIR WORKED WELL. INO RETURNED TO 10 PPM. PATIENT REMAINS IN NICU FOR EXTREME PREMATURITY; ADJUSTED GESTATIONAL AGE = 26 WEEKS. EQUIPMENT WAS PULLED OUT OF SERVICE. SUBSEQUENTLY, RESPIRATORY THERAPY (RT)LEARNED FROM THE COMPANY THAT THE ALARMS HAD OCCURRED BECAUSE THE MACHINE WAS NOT SET UP CORRECTLY. WHEN RT SWITCHED TO NEW INO MACHINES, THEY WERE NOT TOLD BY COMPANY THAT SET UP FOR NITRIC WOULD BE DIFFERENT IN WHERE THEY PLACED IT IN LINE WITH THE CIRCUIT. WITH THE OLD SYSTEM, RT PUT THE INJECTOR MODULE THAT SUPPLIES THE NITRIC AT THE VENT, BUT WITH THE NEW SYSTEM, RT NEEDS TO PUT IT AT THE HEATER DUE TO THE FLOW THAT COMES OUT OF THE SERVO I WITH THE NEW SYSTEM. AFTER DISCUSSION WITH IKARIA (COMPANY), RT EDUCATED THEIR STAFF AND POSTED PICTURES OF WHAT THE NEW SET-UP SHOULD LOOK LIKE. THE MEDICAL GAS DELIVERY SYSTEM INVOLVED IN THIS EVENT WAS RENTAL EQUIPMENT AND WAS RELEASED TO THE MANUFACTURER AFTER 8/30/2013.====================== MANUFACTURER RESPONSE FOR MEDICAL GAS DELIVERY SYSTEM, INO MAX DSIR (PER SITE REPORTER).====================== MANUFACTURER DISCUSSED CORRECT SET-UP WITH RESPIRATORY THERAPY MANAGER (B)(4) 2013. STAFF WERE RE-EDUCATED AND RT POSTED PICTURES OF WHAT THE NEW SET-UP SHOULD LOOK LIKE.