MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-05-25 for CERNER MILLENNIUM POWERORDERS RELEASE 2012.01.42 THROUGH 2015.01.07. manufactured by Cerner Corporation.
[45888873]
Cerner distributed a priority review (b)(4) on may 11, 2016 to all potentially impacted client sites. The software notification includes a description of the issue, an alternative workflow and notification that a software modification has been developed to address the issue for all sites that could be potentially impacted. Cerner corporation? Considers this issue to be resolved and no further narrative is required for follow-up.
Patient Sequence No: 1, Text Type: N, H10
[45888874]
The issue involves cerner millennium powerorders, when you place a prn orderable item with a one-time frequency, the stop date and time may not be removed. As a result, the orderable item may enter a completed status and be removed from the order profile before it can be administered. In some prn medications for varied medical conditions such as seizure medication can be administered as prn thus the potential for non-serious injury to the patient would be present. Cerner has not received communication on any adverse patient events as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1931259-2016-00008 |
| MDR Report Key | 5678334 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-05-25 |
| Date of Report | 2016-05-26 |
| Date of Event | 2015-11-06 |
| Date Mfgr Received | 2015-11-06 |
| Device Manufacturer Date | 2015-06-03 |
| Date Added to Maude | 2016-05-25 |
| 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 | MS SHELLEY LOOBY |
| Manufacturer Street | 2800 ROCKCREEK PARKWAY |
| Manufacturer City | KANSAS CITY MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal | 64117 |
| Manufacturer Phone | 8162011368 |
| Manufacturer G1 | CERNER CORPORATION |
| Manufacturer Street | 2800 ROCKCREEK PARKWAY |
| Manufacturer City | KANSAS CITY MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64117 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERNER MILLENNIUM POWERORDERS |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2016-05-25 |
| Model Number | RELEASE 2012.01.42 THROUGH 2015.01.07. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERNER CORPORATION |
| Manufacturer Address | 2800 ROCKCREEK PARKWAY KANSAS CITY MO 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-25 |