MEDICATION ADMINISTRATION RECORD
Report
- Report Number
- 1931259-2023-00001
- Event Type
- Malfunction
- Date Received
- January 23, 2023
- Date of Event
- November 10, 2022
- Report Date
- July 3, 2023
- Manufacturer
- CERNER CORPORATION
- Product Code
- LNX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 501
Narratives
CERNER DISTRIBUTED A FLASH NOTIFICATION ON JUNE 29, 2023 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE, AND 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. CERNER DISTRIBUTED A FLASH NOTIFICATION ON JANUARY 20, 2023 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE, AND A SOFTWARE MODIFICATION IS BEING DEVELOPED TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED.
CERNER DISTRIBUTED A FLASH NOTIFICATION ON (B)(6) 2023 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE, AND 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.
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 MEDICATION ADMINISTRATION RECORD, 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 MILLENNIUM MEDICATION ADMINISTRATION RECORD. THE ISSUE AFFECTS USERS THAT UTILIZE THE ORM CONTINUING ORDER UPDATE CERNER MILLENNIUM OPERATIONS JOB TO COMPLETE QUALIFYING ORDERS. IN CERNER MILLENNIUM, THE ORM CONTINUING ORDER UPDATE OPERATIONS JOB MAY NOT COMPLETE ALL QUALIFYING ORDERS WHEN MULTIPLE CONTINUOUS INFUSION ORDERS EXIST ACROSS PATIENTS THAT HAVE EITHER MET OR EXCEEDED THEIR ORDERED NUMBER OF DOSES AND HAVE REACHED THEIR STOP DATE AND TIME.. PATIENT CARE COULD BE ADVERSELY AFFECTED IF A MEDICATION ORDER IS NOT INACTIVATED AS EXPECTED, AS MEDICATION MAY BE ADMINISTERED BEYOND THE PRESCRIBED DOSAGE. CERNER RECEIVED A REPORT THAT ONE PATIENT RECEIVED MULITPLE BAGS OF FLUID WHEN THE CONFINUOUS ORDER WAS PLACED FOR ONE BAG. NO FURTHER INFORMATION WAS PROVIDED BY THE CLIENT RELATED TO THIS ISSUE.
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 MEDICATION ADMINISTRATION RECORD, 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 MILLENNIUM MEDICATION ADMINISTRATION RECORD. THE ISSUE AFFECTS USERS THAT UTILIZE THE ORM CONTINUING ORDER UPDATE CERNER MILLENNIUM OPERATIONS JOB TO COMPLETE QUALIFYING ORDERS. IN CERNER MILLENNIUM, THE ORM CONTINUING ORDER UPDATE OPERATIONS JOB MAY NOT COMPLETE ALL QUALIFYING ORDERS WHEN MULTIPLE CONTINUOUS INFUSION ORDERS EXIST ACROSS PATIENTS THAT HAVE EITHER MET OR EXCEEDED THEIR ORDERED NUMBER OF DOSES AND HAVE REACHED THEIR STOP DATE AND TIME.. PATIENT CARE COULD BE ADVERSELY AFFECTED IF A MEDICATION ORDER IS NOT INACTIVATED AS EXPECTED, AS MEDICATION MAY BE ADMINISTERED BEYOND THE PRESCRIBED DOSAGE. CERNER RECEIVED A REPORT THAT ONE PATIENT RECEIVED MULITPLE BAGS OF FLUID WHEN THE CONFINUOUS ORDER WAS PLACED FOR ONE BAG. NO FURTHER INFORMATION WAS PROVIDED BY THE CLIENT RELATED TO THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 408414 | MEDICATION ADMINISTRATION RECORD | SOFTWARE | LNX | CERNER CORPORATION | 2018.02 - 2018.14 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |