FDA Adverse Event Summary report: N

INOMAX

MDR report key: 4538528 · Received February 4, 2015

Report

Report Number
4538528
Date Received
February 4, 2015
Report Date
February 4, 2015
Manufacturer
INO THERAPEUTICS LLC/DBA IKARIA
Product Code
MRN
Report Source
User Facility report
Reporter Location
MI, US
Reporter Occupation
INVALID DATA

Narratives

Description of Event or Problem · 1

PATIENT WAS ON PURITAN BENNETT 840, HEATED WIRE CIRCUIT, AIRWAY PRESSURE RELEASE VENTILATION WITH INOVENT TIED IN TO THE PB840 CIRCUIT DELIVERING NITRIC OXIDE. WHILE DRAINING THE WATER FROM THE VENT CIRCUIT, THE INOVENT ALARMED THAT NITRIC OXIDE WAS NO LONGER BEING DELIVERED AND PATIENT BEGAN TO DESAT TO 82%. INOVENT SAMPLE LINE WAS CHANGED OUT ALONG WITH THE INOVENT MODULE. ALARM DID NOT RESOLVE SO THE ENTIRE INOVENT UNIT WAS SWAPPED OUT FOR ANOTHER INOVENT UNIT. THE REPLACEMENT INOVENT UNIT HAD THE CAL GAS/TEST TANK ON IT WHICH IS IDENTICAL TO THE REGULAR NITRIC OXIDE TANKS (EXCEPT FOR A SMALL 5X8" TEST/CAL GAS LABELING CARD CABLED ON TO THE TANK BY THE MANUFACTURER). PATIENT WAS ACCIDENTALLY CONNECTED TO CAL/TEST TANK BUT THE PATIENT'S SPO2 IMMEDIATELY IMPROVED TO 95%-96%. THE TECHNICIAN DID NOT SEE THE SMALL 5X8" WARNING CARD AFFIXED TO THE NITRIC OXIDE TANK WHICH READ "FOR TESTING & MAINTENANCE...AND STAFF TRAINING ONLY" AS THE CARD AFFIXED TO THE TANK WAS TURNED AROUND UNDERNEATH THE MACHINE AND COULD NOT BE SEEN.PREVIOUS VERSION OF THIS CARD WAS A LARGER RED COLORED TAG THAT PROVIDED IMMEDIATE, ACCURATE IDENTIFICATION OF A TEST TANK.====================== MANUFACTURER RESPONSE FOR IKARIA INOMAX NITRIC OXIDE TEST REMOVABLE CYLINDER, IKARIA INOMAX DELIVERY SYSTEM (PER SITE REPORTER)======================NO RESPONSE AS OF THE DATE OF THIS REPORT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
80907 INOMAX APPARATUS, NITRIC OXIDE MRN INO THERAPEUTICS LLC/DBA IKARIA * 14FP-0543

Patients

Seq Age Sex Outcome Treatment
1 37 YR NO OTHER DEVICES