MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-03 for BRIDGE TRANSFUSION ADMINISTRATION AND SPECIMEN COLLECTION 3.4.7-3.4.13, 2013.01.01- 2017.01.04 N/A manufactured by Cerner Corporation.
[104423885]
(b)(4). Cerner distributed a priority review flash notification on march 27, 2018 to all potentially impacted client sites. The software notification includes a description of the issue and explains that a software modification is being developed to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the software modification is available.
Patient Sequence No: 1, Text Type: N, H10
[104423886]
This report documents information related to an issue reported in association with functionality included in cerner bridge? Transfusion administration and specimen collection. The issue occurs when transactions are sent from cerner bridge transfusion administration and specimen collection to powerchart. These messages can be delayed when the bridge application cannot connect to the port due to network latency. When this occurs, bridge retransmits the unsuccessful messages to powerchart when any subsequent transactions are sent. 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 | 1931259-2018-00006 |
| MDR Report Key | 7393419 |
| Date Received | 2018-04-03 |
| Date of Report | 2018-04-03 |
| Date of Event | 2017-12-14 |
| Date Mfgr Received | 2017-12-04 |
| Device Manufacturer Date | 2012-06-14 |
| Date Added to Maude | 2018-04-03 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BRIDGE TRANSFUSION ADMINISTRATION AND SPECIMEN COLLECTION |
| Generic Name | SOFTWARE, PRODUCT CODE: MMH |
| Product Code | MMH |
| Date Received | 2018-04-03 |
| Model Number | 3.4.7-3.4.13, 2013.01.01- 2017.01.04 |
| 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 | 2018-04-03 |