MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-09-12 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ikaria.
[2978668]
Device misuse [device misuse]. Patient coded [cardio-respiratory arrest] ([heart rate decreased], [oxygen saturation decreased], [blood pressure decreased]). Case description: this initial serious, spontaneous case report was received on (b)(6) 2012, from a respiratory therapist in the united states regarding an (b)(6) male who coded after inomax delivery was interrupted due to device misuse. The patient recovered and two days later, after the patient's status was switched to palliative care only and inomax was discontinued, the patient died. Additional information obtained on (b)(6) 2012, was processed with the initial report. Relevant medical history/co-morbidities: cardiovascular disease (surgery nos (b)(6) 2012); pulmonary hypertension. Relevant concomitant medications: nebulizer treatment (nos); flolan. The respiratory therapist contacted (b)(4) customer care to report that inomax dsir device # (b)(4) alarmed delivery failure while in use on a patient. On (b)(6) 2012, an (b)(6) male underwent surgery for a cardiovascular disorder (nos). Following surgery, he was transferred to the intensive care unit on an avea ventilator and flolan (epoprostenol sodium). Despite treatment with flolan, the patient's pulmonary artery pressure remained high (values not provided) and on (b)(6) 2012 at 08:15, he was started on inomax at a dose of 80 ppm via inomax dsir device # (b)(4). Since orders had been changed from nebulizer to metered dose inhaler treatments, on (b)(6) 2012, a respiratory therapist disconnected the inspiratory limb of the ventilator circuit in order to place a metered dose inhaler adapter into the circuit. The inomax dsir device # (b)(4) alarmed, started to monitor negative numbers and then went into delivery failure. The respiratory therapist quickly reconnected the ventilator circuit but at that moment, the patient coded (heart rate decreased [values unknown], blood pressure decreased to 50/37 [baseline 91/41] and oxygen saturation decreased to 77% [baseline 98-100%]). Within seconds, the respiratory therapist started to manually deliver inomax and oxygen to the patient using the inoblender, while inomax dsir device # (b)(4) was switched out and advanced cardiopulmonary life support (acls) protocol was followed. The patient recovered (exact timeframe unknown) and the patient's heart rate, blood pressure and oxygen saturation returned to baseline. The patient continued treatment with inomax until (b)(6) 2012, when the patient's status was switched to palliative care only. Treatment with inomax was discontinued at 03:26 on (b)(6) 2012 and at 03:30, the patient expired (pulseless electrical activity, no breathing, no blood pressure). The respiratory therapist considered the patient's code (decreased heart rate, decreased blood pressure, and decreased oxygen saturation) to be definitely related to the interruption of nitric oxide flow when the ventilator circuit was broken and the device went into delivery failure. The respiratory therapist considered the patient's death to be due to the patient's medical condition and the decision to switch the patient to palliative care (which included the discontinuation of treatment with inomax).
Patient Sequence No: 1, Text Type: D, B5
[10165901]
On (b)(6) 2012, a respiratory therapist reported that inomax dsir device # (b)(4) alarmed a delivery failure while in use on a patient ((b)(6)). Evaluation summary: the device investigation summary is as follows: examination of the service log conducted when the device was returned to the (b)(4) service center revealed a drug under-delivery condition attributable to high gas flows in the inspiratory limb of the ventilator that were beyond the operating specifications of the inomax dsir, as measured by the injector module. The high measured ventilator flow was due to the user opening the ventilator circuit. The ventilator flow rate was reaching a peak of 120 liters per minute with the nitric oxide dose set at 80 ppm. The inomax dsir design specifies a maximum nitric oxide dose of 40 ppm with a 120 liters per minute ventilator flow rate. When the measured nitric oxide dose was determined to be less than the set dose, the inomax dsir alarmed and went into delivery shutdown, as designed. When the user conducted a pre-use checkout procedure on the device under the direction of (b)(4) technical support, it performed to specifications. When the device was evaluated by (b)(4) service technicians, the condition could not be duplicated, when operated within specifications. The root cause of this incident is use error related to opening the ventilator circuit and possibly related to the interruption of no delivery. Additional staff training will be provided at the facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2012-00008 |
| MDR Report Key | 2743866 |
| Report Source | 05 |
| Date Received | 2012-09-12 |
| Date of Report | 2012-08-16 |
| Date of Event | 2012-08-15 |
| Date Mfgr Received | 2012-08-16 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2012-09-14 |
| 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 DR. |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal | 53718 |
| Manufacturer Phone | 6083953910 |
| Manufacturer G1 | IKARIA |
| Manufacturer Street | 2902 DAIRY DR. |
| 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 | 2012-09-12 |
| 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 | 1. Life Threatening; 2. Other | 2012-09-12 |