MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-21 for PHARMNET INPATIENT - NOT A MEDICAL DEVICE 2012.01 THROUGH 2015.01 N/A manufactured by Cerner Corporation.
[24710278]
Cerner distributed a priority review flash notification pr15-0202-0 on august 7, 2015 to all potentially impacted client sites. The flash notification includes a description of the issue and notifies clients of cerner's plans to provide a software correction to address the issue. Additionally, the flash notifies clients of alternate steps until the issue is resolved. Cerner corporation will provide a follow-up report when the software modifications are available.
Patient Sequence No: 1, Text Type: N, H10
[24710279]
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 pharmnet inpatient nor are these products currently actively regulated by the fda. This report documents information related to an issue identified with functionality included in cerner's pharmnet inpatient (phamedmgr. Exe opened from pharmacy medication manager). The issue involves pharmacy medication manager where the system does not add medications to be evaluated for interaction checking after an order is canceled from a pending submit state. The pharmacist would not get interaction checking and there is no warning that the interaction checking failed. This issue could lead to patient's receiving medications that cause a clinically significant drug interaction or receive duplicate medication therapy, both of which could harm the patient. Cerner has not received communication on any adverse patient events as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
[37126680]
Cerner distributed a priority review flash notification (b)(4) on august 7, 2015 to all potentially impacted client sites. The flash notification includes a description of the issue and notifies clients of cerner's plans to provide a software correction to address the issue. Additionally, the flash notifies clients of alternate steps until the issue is resolved. Cerner distributed an updated priority review flash notification on october 15, 2015 to all potentially impacted client sites. The software notification includes a description of the issue, an alternative to prevent the issue from occurring, and notification that a software modification has been developed and is available to address the issue for all sites that could be potentially impacted. Carner corporation considers the issue resolved and no further narrative is required for follow-up.
Patient Sequence No: 1, Text Type: N, H10
[37126681]
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 pharmnet inpatient, nor are these products currently actively regulated by the fda. This report documents information related to an issue identified with functionality included in cerner's pharmnet inpatient (phamedmgr. Exe opened from pharmacy medication manager). The issue involves pharmacy medication manager where the system does not add medications to be evaluated for interaction checking after an order is canceled from a pending submit state. The pharmacist would not get interaction checking and there is no warning that the interaction checking failed. This issue could lead to patient's receiving medications that cause a clinically significant drug interaction or receive duplicate medication therapy, both of which could harm the patient. 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 | 1931259-2015-00005 |
| MDR Report Key | 5022128 |
| Date Received | 2015-08-21 |
| Date of Report | 2015-08-21 |
| Date of Event | 2015-05-08 |
| Date Mfgr Received | 2015-05-08 |
| Device Manufacturer Date | 2015-05-06 |
| Date Added to Maude | 2015-08-21 |
| 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 MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal | 64117 |
| Manufacturer Phone | 8162011368 |
| Manufacturer G1 | CERNER CORPORATION |
| Manufacturer Street | 2800 ROCKCREEK PARKWAY |
| Manufacturer City | KANSAS MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHARMNET INPATIENT - NOT A MEDICAL DEVICE |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2015-08-21 |
| Model Number | 2012.01 THROUGH 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 MO 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-21 |