MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-08-02 for CERNER MILLENNIUM CARE ADMINISTRATION & CERNER MEDICATION ADMINISTRATION (MAR) 2007.19 - 2015.01 N/A manufactured by Cerner Corporation.
[50936769]
Cerner distributed a priority review flash notification on august 1, 2016 to all potentially impacted client sites. The client notification includes a description of the functionality and notice that a safety enhancement is being developed. Cerner corporation will provide a follow-up report when the safety enhancement is available.
Patient Sequence No: 1, Text Type: N, H10
[50936770]
The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product. The company's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for products such as cerner's millennium care administration or cerner millennium medication administration record (mar), nor are these products currently actively regulated by the fda. This report documents information related to functionality of cerner millennium care administration and cerner millennium medication administration record (mar). When a user opens the medication charting window from the medication administration record or medication administration wizard, the performed date box is active by default. If the user inadvertently presses a hot key (h, k, m, r, t, w, or y), then the date in the performed date box is populated. Cerner received a report of an adverse event where a user's inadvertent use of a hotkey in the performed date field may have contributed to patient receiving an additional dose of medication.
Patient Sequence No: 1, Text Type: D, B5
[55798317]
Cerner distributed a priority review flash notification on august 1, 2016 to all potentially impacted client sites. The client notification includes a description of the functionality and notice that a safety enhancement is being developed. Cerner distributed a priority review flash notification on september 20, 2016 to all potentially impacted client sites. The client notification includes a description of the functionality and notice that the safety enhancement is available. Cerner corporation considers the issue to be resolved and no further narrative is required for follow-up.
Patient Sequence No: 1, Text Type: N, H10
[55798318]
The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product. This report documents information related to functionality of cerner millennium care administration and cerner millennium medication administration record (mar). When a user opens the medication charting window from the medication administration record or medication administration wizard, the performed date box is active by default. If the user inadvertently presses a hot key (h, k, m, r, t, w, or y), then the date in the performed date box is populated. Cerner received a report of an adverse event where a user's inadvertent use of a hotkey in the performed date field may have contributed to patient receiving an additional dose of medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1931259-2016-00010 |
| MDR Report Key | 5840092 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-08-02 |
| Date of Report | 2016-09-22 |
| Date of Event | 2016-07-18 |
| Date Mfgr Received | 2016-06-09 |
| Device Manufacturer Date | 2009-07-03 |
| Date Added to Maude | 2016-08-02 |
| 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 | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERNER MILLENNIUM CARE ADMINISTRATION & CERNER MEDICATION ADMINISTRATION (MAR) |
| Generic Name | SOFTWARE - NOT A MEDICAL DEVICE |
| Product Code | LNX |
| Date Received | 2016-08-02 |
| Model Number | 2007.19 - 2015.01 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Death | 2016-08-02 |