MAUDE Adverse Event Report: CERNER CORPORATION CAREAWARE INFUSION MANAGEMENT, CONNECT NURSING; SOFTWARE

Model Number CAREAWARE INFUSION MANAGEMENT 8.1.0 CONTINUED IN H10

Device Problem Computer Software Problem (1112)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on (b)(6) 2020 and an update notification on (b)(6) 2020 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.Connect nursing (android) 2.5.0.

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 careaware infusion management ® and connect nursing®, 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 careaware infusion management® and connect nursing®.The issue involves cerner's careaware infusion management and connect nursing and affects users that utilize the careaware infusion management and connect nursing along with an infusion pump.When the user uses careaware infusion management and connect nursing, it is possible for the hourly volumes to be doubled due to duplicate correlations.This issue can occur when infusion devices are associated with an order or patient in connect nursing.Patient care could be adversely affected, as clinicians could base further treatment decisions on inaccurate, previously administered infusion volumes for which the discrepancy is clinically significant.This issue could result in adverse patient care.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on march 06,2020 and an update notification on march 19,2020 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 april 27,2021 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.D4: connect nursing (android) releases between connect nursing (android) 2.0.0 and connect nursing (android) 2.8.0.

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 careaware infusion management ® and connect nursing®, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in careaware infusion management® and connect nursing®.The issue involves careaware infusion management and connect nursing and affects users that utilize the careaware infusion management and connect nursing along with an infusion pump.When the user uses careaware infusion management and connect nursing, it is possible for the hourly volumes to be doubled due to duplicate correlations.This issue can occur when infusion devices are associated with an order or patient in connect nursing.Patient care could be adversely affected, as clinicians could base further treatment decisions on inaccurate, previously administered infusion volumes for which the discrepancy is clinically significant.This issue could result in adverse patient care.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: CAREAWARE INFUSION MANAGEMENT, CONNECT NURSING
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• MDR Report Key: 9881175
• MDR Text Key: 205285069
• Report Number: 1931259-2020-00005
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAREAWARE INFUSION MANAGEMENT 8.1.0 CONTINUED IN H10
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1