INOMAX DSIR (DELIVERY SYSTEM)

Report

Report Number: 3004531588-2013-00015
Event Type: Other
Date Received: June 17, 2013
Date of Event: April 30, 2013
Report Date: May 21, 2013
Manufacturer: IKARIA
Product Code: MRN
PMA / PMN Number: K061901
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ON (B)(6) 2013 IKARIA RECEIVED (B)(4) FROM THE FDA, REGARDING A MEDICAL DEVICE COMPLAINT INVOLVING INOMAX DSIR (B)(4) "THAT ALARMED LOW NO DELIVERY FAILURE WHILE ON A PT." EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR SERVICE INVESTIGATION. EVALUATION OF THE SERVICE LOG REVEALED THAT THE REPORTED DELIVERY FAILURE WAS CAUSED BY MONITORED NO READING GREATER THAN (B)(6) PPM. THE HOSPITAL REPORTED OBSERVING A LOW NO ALARM AND FURTHER EVALUATION OF THE LOG REVEALED THAT ONCE THE DELIVERY FAILURE ALARM OCCURRED AND NO DELIVERY STOPPED, A LOW NO ALARM THEN ALSO OCCURRED APPROXIMATELY ONE MINUTE LATER. THE LOG ALSO INDICATED THAT THE AVERAGE VENTILATOR CIRCUIT FLOW THROUGH THE INJECTOR MODULE (IM) WAS (B)(6) LITER PER MINUTE (IPM) WHICH IS WELL BELOW THE LOW LIMIT FOR IM FLOW OF (B)(4) THAT IS IDENTIFIED IN THE DEVICE LABELING. NO DELIVERY AT IM FLOWS BELOW (B)(4) CAN BECOME INCONSISTENT AND IS THE MOST LIKELY CAUSE OF THE DELIVERY FAILURE DUE TO THE MONITORED NO READING EXCEEDING (B)(4) PPM. THE INOMAX DSIR WAS THEN FUNCTIONALLY TESTED PRIOR TO PERFORMING ANY SERVICE ACTIVITY USING DOSE SETTINGS OF (B)(4) PPM AND THE DEVICE PERFORMED WITHIN SPECIFICATIONS AT ALL OF THESE SETTINGS. SINCE THE DEVICE PERFORMED WITHIN SPECIFICATIONS AND NO MALFUNCTION WAS OBSERVED, THE DEVICE WAS CALIBRATED AND RETURNED TO THE DEVICE SERVICE POOL FOR DISTRIBUTION. AS NOTED, THE HOSPITAL INITIALLY REPORTED THAT THE "DEVICE POWERS ON AND OFF WHILE ON PT." IF THIS HAD OCCURRED, THE SERVICE LOG WOULD INDICATE INITIATION OF A NEW BOOT SEQUENCE EACH TIME THIS OCCURRED BUT EVALUATION OF THE LOG REVEALED THAT THE TREATMENT OF THE AFFECTED PT OCCURRED IN A SINGLE BOOT SEQUENCE, SO THIS OBSERVATION COULD NOT BE CONFIRMED. THE ROOT CAUSE FOR THIS INCIDENT WAS USE ERROR AS THE INOMAX DSIR WAS OPERATED WITH AN IM FLOW LESS THAN THE MINIMUM SPECIFIED IN THE DEVICE LABELING. THIS WAS ACKNOWLEDGED BY THE MANAGER OF BIOMEDICAL ENGINEERING IN A TELEPHONE CONVERSATION WITH IKARIA PERSONNEL ON (B)(6) 2013. IT SHOULD BE NOTED THAT THIS MDR IS BEING SUBMITTED IN RESPONSE TO A VOLUNTARY (B)(4) REPORT SUBMITTED BY THE HOSPITAL, AS IS IKARIA'S PRACTICE. A MEDWATCH FORM WAS NOT SUBMITTED AT THE TIME THE EVENT WAS ORIGINALLY REPORTED TO IKARIA BY THE HOSPITAL BECAUSE THERE WAS NO INDICATION THAT SERIOUS INJURY HAD OCCURRED TO THE PT AND NO DEVICE MALFUNCTION WAS DETECTED.

Description of Event or Problem · 1

LOW NO DELIVERY FAILURE [DEVICE ISSUE]. OXYGEN SATURATION DROPPED FROM 83% TO 77% [OXYGEN SATURATION DECREASED]. CASE DESCRIPTION: ON (B)(6) 2013 IKARIA RECEIVED (B)(4), REGARDING A MEDICAL DEVICE COMPLAINT INVOLVING AN INOMAX DSIR ((B)(4)). THE VOLUNTARY REPORT WAS FILED ON (B)(6) 2013 BY THE RISK MANAGEMENT DEPARTMENT OF A HOSPITAL IN THE UNITED STATES. IT STATES THAT ON (B)(6) 2013, AN INOMAX DEVICE ((B)(4)) THAT WAS IN USE ON A "PEDIATRIC PT BEING TRANSFERRED FROM ICU TO OPERATING ROOM" BEGAN "ALARMING AND READ 'LOW NO DELIVERY FAILURE' AND A BIG RED X APPEARED ON THE NO CONTROL DIAL ON THE SCREEN." A SEARCH OF THE IKARIA COMPLAINT REPORTING DATABASE REVEALED A COMPLAINT RECEIVED BY IKARIA CUSTOMER CARE (CC) FROM THIS HOSPITAL ON (B)(6) 2013 ((B)(4)). THE BIOMEDICAL DEPARTMENT TECHNICIAN CALLED TO REPORT THAT INOMAX DSIR "(B)(4) WAS REPEATEDLY POWERING OFF AND ON WHILE ON PT." IKARIA TECHNICAL SERVICES SPOKE WITH THE BIOMEDICAL TECHNICIAN; HOWEVER, HE WAS UNABLE TO PROVIDE ADDITIONAL INFO AT THAT TIME. ON (B)(6) 2013 IKARIA TECHNICAL SERVICES CALLED THE BIOMEDICAL TECHNICIAN TO DISCUSS THE COMPLAINT IN MORE DETAIL AND REQUEST RETURN OF THE DEVICE TO IKARIA FOR INSPECTION. THE BIOMEDICAL TECHNICIAN STATED THAT HE WAS "UNABLE TO PROVIDE ANY INFO" AS "THE DEVICE IS BEING HELD UNDER [HOSPITAL] GENERAL INVESTIGATION". ON (B)(6) 2013, DURING A CALL FROM THE HOSPITAL'S ASSOCIATE CLINICAL ENGINEER, IT WAS REPORTED THAT "WHILE TRANSPORTING A PT, A DELIVERY FAILURE OCCURRED" AND THE "PT'S O2 SAT WAS 83% AND DECREASED TO 77% FOR A SHORT PERIOD OF TIME, WHILE BEING BAGGED" ((B)(4)). IKARIA REQUESTED THE DEVICE BE RETURNED FOR INSPECTION AND WAS INFORMED THAT THE DEVICE HAD BEEN SEQUESTERED BY THE HOSPITAL'S BIOMED AND WOULD NOT BE RETURNED TO IKARIA UNTIL THE DEPARTMENT COMPLETED ITS OWN INVESTIGATION. ON (B)(6) 2013 IKARIA CONTACTED THE HOSPITAL'S BIOMED AGAIN TO ARRANGE FOR RETURN OF THE DEVICE. THE ASSOCIATE CLINICAL ENGINEER AT THE HOSPITAL REFUSED TO RELEASE THE DEVICE BECAUSE THE HOSPITAL'S RISK MANAGEMENT WAS NOT DONE WITH THE INVESTIGATION. ON (B)(6) 2013 THE INOMAX DSIR (B)(4) WAS RELEASED BY THE HOSPITAL AND RETURNED TO IKARIA'S REGIONAL SERVICE CENTER FOR INSPECTION. ON (B)(6) 2013 IKARIA CONTACTED THE HOSPITAL'S RISK MANAGER TO OBTAIN ADDITIONAL INFO ABOUT THE COMPLAINT AND EVENT. THE RISK MANAGER STATED SHE WOULD NOT PROVIDE ANY MORE INFO AND WOULD BE SUBMITTING A (B)(4) REPORT TO THE FDA. ON (B)(6) 2013 IKARIA CALLED THE MANAGER OF BIOMEDICAL ENGINEERING TO PROVIDE A REPORT OF INVESTIGATION FINDINGS, AS THEY REQUESTED, FOR INOMAX DSIR (B)(4). THE FINDINGS INDICATED, AND THE MANAGER AGREED, THAT THE DEVICE WAS IMPROPERLY SET (NOT MEETING PARAMETERS SET BY THE DSIR OPERATING MANUAL) AND WAS IMPROPERLY MAINTAINED. HE REQUESTED RETRAINING FOR HOSPITAL STAFF. ON (B)(6) 2013 THE IKARIA DIRECTOR OF TECHNICAL SERVICES AND IKARIA CLINICAL SPECIALIST FOR THIS HOSPITAL MADE AN ON-SITE VISIT TO THE HOSPITAL TO DISCUSS THE RESULTS OF THE SERVICE EVALUATION FOR THIS DEVICE WITH RESPIRATORY AND BIOMEDICAL ENGINEERING, ATTEMPT TO GATHER MORE INFO RELATED TO THE REPORTED ISSUE AND PRESENT POSSIBLE TRAINING OPTIONS TO THE CUSTOMER. THE ASSOCIATE DIRECTOR OF RESPIRATORY CARE STATED THAT HE FELT "THIS ISSUE THAT OCCURRED IN THE OPERATING ROOM WAS A ONE-TIME EVENT AND DID NOT NECESSITATE AN EXTENSIVE DEPARTMENT WIDE TRAINING." ON (B)(6) 2013 AND (B)(6) 2013, ADDITIONAL INFO PERTAINING TO THE (B)(4) REPORT WAS OBTAINED FROM THE RISK MANAGER. THE PT WAS A (B)(6) MALE INFANT WITH HISTORY OF TRICUSPID ATRESIA, TRUNCUS ARTERIOSUS WITH MAJOR AORTO-PULMONARY COLLATERAL ARTERIES (MAPCAS) AND PULMONARY HYPERTENSION. HE WAS HOSPITALIZED ON AN UNKNOWN DATE FOR CARDIAC PROBLEMS AND TRICUSPID ATRESIA. THE PT WAS INTUBATED AND ON THE SERVO-I, SIMV/PRVC, TIDAL VOLUME 95ML, RATE 28, FRACTION OF INSPIRED OXYGEN (FIO2) 70%, POSITIVE END-EXPIRATORY PRESSURE (PEEP) 6 CM H2O PRESSURE, PRESSURE SUPPORT 10. ON (B)(6) 2013 AT 23:07 THE PT WAS STARTED ON INOMAX AT 20 PARTS PER MILLION (PPM) FOR PULMONARY HYPERTENSION AND IN PREPARATION FOR CARDIAC SURGERY. THE PT'S BASELINE SPO2 WAS 85%. ON (B)(6) 2013, WHILE THE PT WAS BEING TRANSFERRED FROM THE OPERATING ROOM TABLE TO THE TRANSPORT GURNEY (NOT DURING TRANSPORT FROM THE OPERATING ROOM TO THE ICU AS REPORTED IN THE (B)(4) REPORT), THE INOMAX DSIR ((B)(4)) BEGAN ALARMING AND DISPLAYED" LOW NO DELIVERY FAILURE" AND A "BIG RED X APPEARED ON THE NITRIC OXIDE CONTROL DIAL ON THE SCREEN." THE REPORTER STATED THAT "ALL MACHINE CONNECTIONS AND TANK PSI WERE CHECKED AND VERIFIED TO BE WORKING." ACCORDING TO THE REPORTER, "THE PT'S PULSE OXIMETER READING DROPPED BY 6 POINTS FROM 83% TO 77% FOR APPROXIMATELY ONE MINUTE." THE PT'S OTHER VITAL SIGNS REMAINED UNCHANGED. THE PT WAS IMMEDIATELY MANUALLY VENTILATED WITH THE INOBLENDER AND PLACED ON THE BACK-UP DSIR ON STANDBY IN THE OPERATING ROOM (SERIAL NUMBER NOT PROVIDED). THE BACKUP DEVICE FUNCTIONED WITHOUT PROBLEMS. THE INOMAX DSIR (B)(4) WAS REMOVED FROM SERVICE ON (B)(6) 2013 AND RETURNED TO IKARIA ON (B)(6) 2013 FOR SERVICE EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
273749	INOMAX DSIR (DELIVERY SYSTEM)	APPARATUS, NITRIC OXIDE DELIVERY	MRN	IKARIA	10007

Patients

Seq	Age	Sex	Outcome	Treatment
1	1 YR		Other