MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-07 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ikaria.
[4440136]
Monitored no less than set no [device malfunction] patient placed back on bypass while inomax dsir switched out (no adverse event). Case description: on january 17, 2014 a medsun safety report, (b)(4) was received by ikaria from the fda. The report stated that the inomax dsir (b)(4) in use on a patient, was turned to 80 parts per million (ppm) [nitric oxide], but would only reach 20 ppm and slowly went down to 10 ppm. Additional information was obtained from the medsun reporter on january 21, 2014 and is included in this report. On (b)(6) 2013, the office of clinical safety at a hospital in the united states filed a voluntary medsun report with the fda regarding the inomax dsir (b)(4). The report stated that on (b)(6) 2013, "nitric was started, checked all connections, attempted to turn on 80 ppm [but] nitric oxide (no) machine would only reach 20 ppm and slowly went down to 10 ppm. A calibration was performed with no change in delivery. Nitric machine was then shut down, restarted with no results. The patient was [placed] back on bypass until another nitric machine was delivered [hospital] technicians suspect it was a failure of either a bench monitoring pcb or an occlusion of a sample line inside the device that leads to the bench. " a search of the ikaria safety database revealed no associated complaints for the inomax dsir (b)(4) from the reporting hospital during the time frame indicated on the medsun report. A search of the ikaria complaint reporting database revealed a report received by ikaria technical services on (b)(6) 2013 from the rt regarding inomax dsir (b)(4), that "was not in use on a patient" when it had a "measured values issue". The rt stated that "another staff member set the dose to 80ppm when the measured no was only 20ppm. The rt did a performance check when the device only measured room air". Ikaria technical support asked the rt to verify water trap jar placement, filter placement, and sensor cover, and the rt stated "he checked all that and the issue remained". The decision was made to return inomax dsir (b)(4) to ikaria for inspection. Relevant medical history/co-morbidities: a (b)(6) year old adult male patient with history of cardiac disease nos, heart transplant receipt with intra-operative hypoxia occuring on (b)(6) 2013. Relevant concomitant medication: not provided. According to the medsun reporter, on (b)(6) 2013, the patient had heart transplant surgery. In the operation room, the "patient experienced intra-operative hypoxia and was started on inomax at 20 ppm" via inomax dsir (b)(4). The patient remained on inomax at 20 ppm post operatively. According to the progress notes reviewed by the medsun reporter, on (b)(6) 2013, the patient went back to the operating room for "wash out and sternal closure of the incision line". Due to the monitoring issue previously described, the inomax dsir (b)(4) was switched out with another inomax dsir and the patient was transported to icu. At time of transport, the patient was on 20 ppm of inomax. Later that day, they began to wean the patient from inomax. The medsun reporter stated that it appeared, from the surgeon's operative notes, there was no impact to the patient during the inomax dsir issue in the operating room other than placing the patient back on bypass. The patient's vital signs remained stable while waiting for the second inomax dsir to arrive. After follow up with the reporter, it was determined that the inomax dsir (b)(4) was removed from the service and was sent to the hospital's biomedical engineering department and on (b)(6) 2013, when the device was no longer on the patient, the rt called ikaria for technical assistance.
Patient Sequence No: 1, Text Type: D, B5
[11876449]
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 wa not associated with an adverse event to a patient. The inomax dsir device serial number (b)(4) was returned to the manufacturer for service investigation. Examination of the service log confirms the reported complaint of measured no less than set no with low no alarms. A low no alarm occurred while delivering 80 ppm of no with the low alarm set at 5 ppm and actual no reported as 4. 8 ppm. The service investigation identified pinched and damaged water trap jar o-rings consistent with allowing room air to dilute the sampled gas causing the subsequent low no readings. The o-rings were replaced to rectify the fault. The root cause is damaged water trap jar o-rings. This condition will be tracked and trended under ikaria's quality system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2014-00004 |
| MDR Report Key | 3785028 |
| Report Source | 05 |
| Date Received | 2014-02-07 |
| Date of Report | 2014-01-17 |
| Date Mfgr Received | 2014-01-17 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2014-05-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID TRUEBLOOD |
| Manufacturer Street | 2902 DAIRY DRIVE |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal | 53718 |
| Manufacturer Phone | 6083953910 |
| Manufacturer G1 | IKARIA |
| Manufacturer Street | 2902 DAIRY DRIVE |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53718 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOMAX DSIR (DELIVERY SYSTEM) |
| Generic Name | APPARATUS, NITRIC OXIDE DELIVERY |
| Product Code | MRQ |
| Date Received | 2014-02-07 |
| Model Number | 10007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IKARIA |
| Manufacturer Address | MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-07 |