MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-11 for INOMAX DSIR PLUS (DELIVERY SYSTEM) 10007 manufactured by Mallinckrodt Manufacturing Llc..
[180827619]
The system was used for treatment. This case is reportable as a mdr due to the medical intervention of the 100% oxygen as well as the increase in positive end-expiratory pressure (peep) that was provided to the patient. The dsir plus, (b)(4), was returned to the (b)(4) center ((b)(4)) for investigation. A review of the device's service log revealed that a delivery failure alarm occurred due to an apparent inter-processor link (ipl) failure between the device's monitoring processor and delivery processor. The customer also provided a video file that showed the device displaying the delivery failure alarm. Although identified in the service log and in the customer's video, the rsc did not experience a delivery failure alarm during testing. The root cause for this occurrence was likely due to a malfunctioning pca main board. As a result, the device's pca main board was replaced. A full functional test was performed after the pca board replacement and the device operated according to specifications. As a result, the device was placed back into circulation for customer use. An apparent inter-processor link (ipl) failure within the device caused a delivery failure, which resulted in an abrupt discontinuation of nitric oxide to the patient. This abrupt discontinuation of nitric oxide along with the patient's left lung collapse could have contributed to the patient's oxygen desaturation. Thus, the root cause of the patient's oxygen desaturation was likely due to a combination of the device's apparent inter-processor link (ipl) failure and the patient's left lung collapse. Trends were reviewed for complaint categories, delivery failure and oxygen desaturation. No trends were detected for these complaint categories. The assessment is based on information available at the time of the investigation. Complaints are monitored through tracking and trending. If a trend is detected, further investigation will be conducted. Adverse event terms: oxygen saturation, low. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[180827620]
The customer called to report that a patient experienced oxygen desaturation while on the inomax dsir plus. The customer reported that the patient began receiving nitric oxide via the dsir plus utilizing a vapotherm oxygen delivery device on (b)(6) 2019. The customer stated at the time of the event the patient was being ventilated with a draeger v-500 ventilator at the following settings: mode pressure control/volume control, respiratory rate 45 per minute, tidal volume 22cc, positive end-expiratory pressure (peep) 5cmh2o and fraction of inspired oxygen (fio2) at 50%. The customer reported that the patient's baseline oxygen saturation was in the 90% range. The customer stated that she was unable to give a precise oxygen saturation value as it was fluctuating. The customer reported that on (b)(6) 2019 at 08:28 cst, the nursing staff called her for an alarming dsir plus unit. The customer stated that she entered the room within thirty seconds of being notified and noticed a delivery failure alarm on the dsir plus. The customer reported that the patient's oxygen saturation had decreased to 75%. The customer stated the patient did not exhibit either bradycardia or hypotension. The customer stated that she immediately switched on the device's integrated pneumatic back - up in order to reinstate inomax to the patient. The customer reported that the patient's oxygen saturation then rapidly increased to 85%. The customer stated that manual ventilation was not required for the patient. The customer reported that the patient was not receiving any nursing care or having any procedures performed at the time of the incident. The customer stated that patient's inomax treatment continued utilizing the integrated pneumatic backup while a replacement dsir plus was prepared for use. The customer reported that the patient was placed onto the replacement dsir plus without any further incident within three to five minutes of the initial alarm. The customer stated that approximately three hours after the initial incident, the patient was still being maintained on 100% oxygen and their peep had been increased to 7cmh2o in order to maintain the patient's oxygen saturation. The customer reported that a follow up x-ray was performed which indicated that the patient had an extensive left sided atelectasis indicating a complete lung collapse. The customer reported that she felt that the patient's lung collapse may have contributed to the patient's oxygen desaturation and was also contributing to the patient's slow recovery. The customer stated that she felt that the patient's oxygen desaturation was related to the abrupt withdrawal of inomax. The customer reported that that she also felt that the abrupt withdrawal of inomax was due to a device malfunction/issue. The customer reported that once the dsir plus was removed from the patient, they re-booted the device and there were no alarms present. The device was returned for investigation. This medwatch is for the adverse event, oxygen desaturation, that was experienced by the patient. The device malfunction is reported in medwatch 3004531588-2020-00012.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004531588-2020-00018 |
| MDR Report Key | 9696520 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2019-12-12 |
| Device Manufacturer Date | 2008-07-25 |
| Date Added to Maude | 2020-02-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MEGAN VERNAK |
| Manufacturer Street | 1425 US ROUTE 206 |
| Manufacturer City | BEDMINSTER NJ 07921 |
| Manufacturer Country | US |
| Manufacturer Postal | 07921 |
| Manufacturer G1 | MALLINCKRODT MANUFACTURING LLC. |
| Manufacturer Street | 6603 FEMRITE 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 PLUS (DELIVERY SYSTEM) |
| Generic Name | APPARATUS, NITRIC OXIDE DELIVERY |
| Product Code | MRN |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2019-12-17 |
| Model Number | 10007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALLINCKRODT MANUFACTURING LLC. |
| Manufacturer Address | MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-11 |