MAUDE Adverse Event Report: CERNER CORPORATION BRIDGE TRANSFUSION ADMINISTRATION AND SPECIMEN COLLECTION; SOFTWARE, PRODUCT CODE: MMH

Model Number 3.4.7-3.4.13, 2013.01.01- 2017.01.04

Device Problems Computer Software Problem (1112); Application Network Problem (2879)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

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.

Manufacturer Narrative

Unique identifier (udi) number: (b)(4).Note: the udi information included above only pertains to bridge transfusion administration and specimen collection.The other bridge solution affected by this issue (bridge breast milk management) is not a device.Additional narrative cerner distributed updated priority review flash notifications on may 24, 2018 and january 29, 2019 to all potentially impacted client sites.The january 29, 2019 priority review flash notification communicates that a software modification is available 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.

Event Description

This follow-up report provides additional information related to an issue reported in association with functionality included in cerner bridge¿.The issue occurs when transactions are sent from bridge 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.

• Brand Name: BRIDGE TRANSFUSION ADMINISTRATION AND SPECIMEN COLLECTION
• Type of Device: SOFTWARE, PRODUCT CODE: MMH
• Manufacturer (Section D): CERNER CORPORATION; 2800 rockcreek parkway; kansas city MO 64117
• MDR Report Key: 7393419
• MDR Text Key: 104423885
• Report Number: 1931259-2018-00006
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• PMA/PMN Number: BK060037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.4.7-3.4.13, 2013.01.01- 2017.01.04
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1