MAUDE Adverse Event Report: CERNER CORPORATION ORACLE HEALTH TRANSFUSION ADMINISTRATION AND SPECIMEN COLLECTIONS; SPECIMEN COLLECTION ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Model Number	2025.01.01
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of the reported incident is still under investigation.The product's instructions for use clearly directs all users to adhere to the listed operational guideline: "only open bridge medical once in your browser, if you open bridge medical in multiple tabs in the same browser, the application does not work as expected." these instructions are also included in customer training.
Event or Problem Description
On (b)(6) 2025, a user signed into bridge specimen collection software on multiple devices within the department.This resulted in accession numbers for specimens linking to the incorrect patient which ultimately resulted in results being sent to the wrong patient record.The issue has been resolved for the patient's records.Cerner has not received any communication regarding any reports of adverse patient events related to this incident.
Additional Manufacturer Narrative
An internal investigation identified the likely root cause as an improperly terminated session for the previous patient, followed by a subsequent login that reused the stale session object, compounded by incomplete cleanup.Adequate preventative actions have been identified and are currently being implemented, including code modifications and enhanced error messaging to mitigate recurrence.The fix will be released to the impacted clients on version for bridge 2025.01 on (b)(6) 2025, followed by the remaining patch versions for bridge 2024.02 and bridge 2025.02 on december 10, 2025.Cerner will provide another follow-up report after completion of all client communication.
Additional Manufacturer Narrative
Customers with affected software packages were proactively notified through four (4) flash notifications and targeted email communications.Flash notifications were made available in the cerner flashes repository, and email alerts were sent to customers who had opted in.Additional emails informed customers whenever a new service package was available.July 25, 2025-preliminary customer notification (flash25-0215-p) issued to raise awareness of the potential issue and outline the affected software packages.August 19, 2025-follow-up #1 notification (flash25-0215-0) provided an update on preventive solution change cr# 1-000000553352, soon to be available.November 26, 2025-release of solution change 1-000000553352; service package #678621 provided for bridge version 2025.01.06.December 10, 2025-additional release of service package #679540 for bridge version 2024.02.03, relating to solution change cr# 1-000000553352.December 18, 2025-cerner corporation customer service contacted the reporting customer ((b)(6)) to inform about the availability of service packages 678621 and 676364 and requested confirmation on the intended package uptake.December 24, 2025-additional release of service package #679541 for bridge version 2025.02.02, associated with solution change cr# 1-000000553352.January 11, 2026-follow-up #2 notification (flash25-0215-1) advised customers regarding solution change cr# 1-000000553352 and availability of three service packages (#678621, #679540, #679541) for download and implementation.February 02, 2026-follow-up #3 notification (flash25-0215-2) republished (flash25-0215-1) and information was sent to additional email recipients.As of february 3, 2026, eleven (11) customers have installed the resolving code package in a non-production database.One (1) customer has applied the package to their production environment.An additional four (4) customers have downloaded the package but have not yet begun installation, out of forty-five (45) potentially impacted clients.Cerner corporation customer service has received confirmation from the reporting customer, (b)(6), acknowledging receipt of the package and the associated implementation instructions.Oracle cerner considers this event closed.

• Brand Name: ORACLE HEALTH TRANSFUSION ADMINISTRATION AND SPECIMEN COLLECTIONS
• Common Device Name: SPECIMEN COLLECTION ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• 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
• MDR Report Key: 22630250
• Report Number: 1931259-2025-00013
• Device Sequence Number: 18454369
• Product Code: MMH
• UDI-Device Identifier: 00853023006104
• UDI-Public: (01)00853023006104(10)BRG20250101-P662161
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: BK060037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2025.01.01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 09/04/2025; 02/02/2026
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/25/2025; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown