MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-27 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ikaria.
[17607837]
Pre-use checkout procedure was not performed (device misuse) monitored no less than set no (device malfunction) patient crashed (cardio-respiratory arrest) (blood pressure decreased), (heart rate decreased), (oxygen saturation decreased). Case description: this initial serious spontaneous report was received on (b)(4) 2013 from a respiratory therapist (rt) in the united states regarding an infant that "crashed" during a switch out of inomax dsir (ds20090553) due to monitored nitric oxide (no) reading lower than the set no. Additional information received on (b)(4) 2013 was processed with the initial. Relevant medical history/comorbidities included: (b)(6) infant born at 39 weeks gestation on (b)(6) 2013 with congenital heart defects: possible pulmonary atresia with intact ventricular septum and severe pulmonary regurgitation. The infant was transported from another hospital to current hospital in preparation for cardiac surgery. Concomitant medications were not provided. The infant went to the operating room (o. R. ) on (b)(6) 2013 for an atrial septal defect (asd) repair with a fenestrated patch, tricuspid valve repair, right ventricular outflow tract (rvot) procedure and a transannular patch (tap) repair. The infant was started on inomax (inhaled nitric oxide) 20 parts per million (ppm) via the inomax dsir ds20090553 while in the operating room (start time not available) then transported to the pediatric intensive care unit still on therapy. The infant was on the servo-i ventilator fio2 100%, tidal volume (vt) 40 ml, positive end expiratory pressure (peep) + 10, rate 22 breaths per minute, synchronized intermittent mandatory ventilation (simv) with pressure regulated volume control (prvc) modes. According to the rt, post operatively "the infant was very unstable" with baseline blood pressure 80/50 mmhg, heart rate 142 (pacing wires in place, rt not sure if pacing) and baseline oxygen saturation spo2 of 77-78% on 100% fio2. The rt observed the inomax dsir was set on 20 ppm no and measured no was 13 ppm. This discrepancy was present from the start of inomax therapy. During troubleshooting the rt found the injector module (im) placed improperly. She moved the im to the correct position but the set vs. Monitored no problem persisted. Multiple troubleshooting actions, including replacing the im, were performed without a change in the monitored value. A decision was made to switch out the device with a second inomax dsir ds20120348. The patient was manually ventilated using the nioblender with inomax 20 ppm and 100% oxygen. According to the rt, within 30 seconds of starting manual ventilations "the patient crashed". Dropping o2 sats to spo2 50%, bp dropped to 50/26 mmhg and heart rate dropped to 71. The switch out took 2 minutes and the patient was placed back on the servo-i set in neonatal mode, prvc+simv+pressure support (ps), vt 40 ml, peep +10, fio2 100%, respiratory rate 22 and the second dsir ds20120348 set at 20 ppm no and measuring 13 ppm no. The infant was given epinephrine (rt did not know exact number of doses but stated it was more than one) and was started on an epinephrine drip. The infant did not require cardiac massage. The infant's vital signs began to return to baseline bp, hr and spo2 parameters within 30 minutes. The inomax dsir ds20090553 and original injector module was removed from service and will be returned to ikaria for inspection. The second device ds20120348 had the same issue as the first device; set no 23-24 ppm and measured no reading 13ppm. The rt stated the second device passed the pre-use checkout. The rt, who is very experienced with the inomax dsir, was certain the device was set up properly. The infant was on the servo-i ventilator with the same settings with peep decreased to +3. The set no was 23-24 ppm and measuring 13 ppm. The rt contacted ikaria technical support for assistance on (b)(6) 2013 at 1720 shortly after starting no. Multiple troubleshooting actions were performed without a change in the monitored value. The rt stated that "since the patient's vital signs were stabilizing, the physician was satisfied with the (no) measured values at this time" and "with the severity of illness of the patient, she does not want to attempt any other changes". According to the rt, at 07:00 on (b)(6) 2013 the inomax dsir was set to 30 ppm no and measuring 17 ppm no and the patient was too unstable for the rt to do any recalibrations. At 10:45 the "patient crashed again" with spo2 dropping to 67% on servo-i fio2 100%. The rt did not state if the infant required manual ventilation. The infant was administered vasopressors, fentanyl, calcium bolus and volume with 30 cc packed red blood cells (prbc). The rt stated that later that morning the patient stabilized and remained on inomax with set no 30 ppm and monitored no 17 ppm. Servo-i settings remain the same. On (b)(6) 2013 the bedside rt changed the injector module again and this resulted in the measured no equaling the set no. The infant remains on inomax dsir ds20120348 and has been weaned from set no of 30 ppm to 20 ppm with monitored no of 20 ppm. The ventilator settings remain essentially the same however the ventilator rate was increased to 24 and peep was increased to +4. The reporter considers the event of patient crashing and the associated oxygen saturation decrease, decrease in blood pressure and decrease in heart rate as serious and possibly related to the inomax dsir switch out. The rt did not comment as to the event's relationship to inomax. The rt did not comment as to the association of the second instance of patient crashing to inomax or the second inomax dsir device (ds20120348).
Patient Sequence No: 1, Text Type: D, B5
[17645346]
On (b)(6) 2013 a respiratory therapist called to report that inomax dsir device ds20090553 displayed monitored nitric oxide (no) values less than set no dose while in use on patient ((b)(4)). Evaluation summary: the device was returned to the manufacturer for service investigation. The device was tested an a no reading of 12 ppm was observed at a no dose setting of 20 ppm which was consistent with the behavior observed by the rt. Injector module component was replaced with a new injector module and retested. The testing performed with the new injector module passed all tests within specifications. The service log of the device was evaluated and it revealed that the pre-use checkout procedure had not been performed prior to the initial use of the device on the patient as is indicated in the device labeling. It should be noted that had the pre-use checkout procedure been performed prior to use, the performance test section of this procedure would not have passed and the rt would have performed troubleshooting on the device until the issue was resolved and the pre-use checkout procedure was completed successfully. The root cause for this incident was an injector module that failed to meet specifications but the incident could have been avoided had the rt performed the pre-use checkout procedure as indicated in the device labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2013-00005 |
| MDR Report Key | 2984943 |
| Report Source | 05 |
| Date Received | 2013-02-27 |
| Date of Report | 2013-01-29 |
| Date of Event | 2013-01-29 |
| Date Mfgr Received | 2013-01-29 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2013-03-04 |
| 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 | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID TRUEBLOOD, DIRECTOR |
| 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 | MRP |
| Date Received | 2013-02-27 |
| Model Number | 10007 |
| Lot Number | 20002064 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Life Threatening; 2. Other | 2013-02-27 |