MAUDE Adverse Event Report: CERNER CORPORATION MEDICATION ADMINISTRATION RECORD; SOFTWARE

Model Number 2018.02 - 2018.14

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: MEDICATION ADMINISTRATION RECORD
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer (Section G): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer Contact: jeff mauzey ; 8779 hillcrest road; kansas city, MO 64138 ; 8162011368
• MDR Report Key: 16225402
• MDR Text Key: 309058656
• Report Number: 1931259-2023-00001
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2018.02 - 2018.14
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1