MAUDE Adverse Event Report: CERNER CORPORATION CONNECT NURSING; SOFTWARE

Model Number REFER TO H10

Device Problem Computer Software Problem (1112)

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

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on october 2, 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.

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 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 millennium connect nursing® (android) webservice.The issue involves cerner millennium connect nursing and affects users that utilize this product with careaware smart pump programming to facilitate the documentation of nursing activities and support the administration of medications.When a user begins and signs the administration of a first bag for a continuous infusion in connect nursing and then modifies the rate on the infusion pump but does not sign the modified rate in any application, the modified rate from the pump is not recognized by connect nursing.If a subsequent bag were to be administered from connect nursing, the last signed rate for the infusion is displayed in the charting details instead of the rate at which the pump is currently infusing.As a result, medication could be administered at the incorrect rate rather than the intended rate.Cerner has not received communication on any adverse patient events as a result of this issue.

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 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 millennium connect nursing® (android) webservice.The issue involves cerner millennium connect nursing and affects users that utilize this product with careaware smart pump programming to facilitate the documentation of nursing activities and support the administration of medications.When a user begins and signs the administration of a first bag for a continuous infusion in connect nursing and then modifies the rate on the infusion pump but does not sign the modified rate in any application, the modified rate from the pump is not recognized by connect nursing.If a subsequent bag were to be administered from connect nursing, the last signed rate for the infusion is displayed in the charting details instead of the rate at which the pump is currently infusing.As a result, medication could be administered at the incorrect rate rather than the intended rate.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on october 2, 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 december 1, 2021 to all potentially impacted client sites.The software notification includes a description of the issue and indicates that 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 (model number): connect nursing (android) releases between connect nursing (android) web service (may 21, 2019) and medication charting cloud service (november 16, 2021).

• Brand Name: CONNECT NURSING
• 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: shelley looby ; 8779 hillcrest road; kansas city, MO 64138 ; 8162011368
• MDR Report Key: 10645138
• MDR Text Key: 214800278
• Report Number: 1931259-2020-00009
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A#S-P#N/A
• 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: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: REFER TO H10
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2020
• 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