BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEPSIS

    MDR report key: 23510177 · Received November 10, 2025

    Report

    Report Number
    1931259-2025-00018
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 21, 2025
    Report Date
    March 25, 2026
    Manufacturer
    CERNER CORPORATION
    Product Code
    SAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, CERNER'S INTERNAL MONITORING PROCESSES DETECTED THE ISSUE, TRIGGERING AN IMMEDIATE INVESTIGATION. IT WAS DETERMINED THAT A CLIENT-SPECIFIC BACKLOG HAD DELAYED DATA PROCESSING AND, AS A RESULT, SEPSIS NOTIFICATIONS WERE DELAYED FOR APPROXIMATELY 3 HOURS AND 40 MINUTES. THE ROOT CAUSE WAS TRACED TO ANOMALOUS DATA, WHICH WAS IDENTIFIED AND REMOVED, ENABLING NORMAL DATA PROCESSING TO RESUME. CERNER PROMPTLY NOTIFIED THE CLIENT OF THE DELAY. THE CLIENT HAS NOT REPORTED ANY MISSED OR DELAYED SEPSIS NOTIFICATIONS AFFECTING PATIENT CARE DURING THE INCIDENT. THE INVESTIGATION REMAINS IN PROGRESS. CERNER WILL SUBMIT A FOLLOW UP REPORT AT THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CERNER COMPLETED ITS INVESTIGATION OF THIS EVENT AND WAS UNABLE TO CONCLUSIVELY IDENTIFY A SINGLE DEFINITIVE ROOT CAUSE. THROUGH FUNCTIONAL AND REGRESSION TESTING, THE INVESTIGATION IDENTIFIED CONTRIBUTING FACTORS RELATED TO PROCESSING LARGE DATA PAYLOADS, INCLUDING LEGACY SEPSIS DATA-HANDLING LIMITATIONS, RETRY BEHAVIOR THAT CAN PROLONG DELAYS, AND PAYLOAD GROWTH ASSOCIATED WITH CUSTOMER-CONTROLLED DATA. IN THIS EVENT, A CLIENT-SPECIFIC BACKLOG DELAYED SEPSIS NOTIFICATION PROCESSING FOR APPROXIMATELY 3 HOURS AND 40 MINUTES. CERNER RESTORED PROCESSING BY REMOVING ANOMALOUS DATA ASSOCIATED WITH THE BACKLOG AND IMPLEMENTED MEASURES TO REDUCE RECURRENCE, INCLUDING LIMITING RETRIES FOR ANOMALOUS DATA AND ENHANCING LOGGING. CERNER CONSIDERS THIS INVESTIGATION COMPLETE, AND NO FURTHER EVENT-SPECIFIC ACTION IS PLANNED.

    Description of Event or Problem · 0

    THE SOFTWARE PRODUCT REFERENCED IN THIS MEDWATCH REPORT MAY NOT MEET THE DEFINITION OF A MEDICAL DEVICE; HOWEVER, CERNER HAS VOLUNTARILY FILED THIS REPORT TO INFORM THE FDA OF THE RESOLUTION OF A MALFUNCTION ASSOCIATED WITH THE PRODUCT. THIS ISSUE AFFECTED THE CERNER MILLENNIUM SEPSIS MODULE WITHIN A CLOUD-BASED SOLUTION AND WAS LIMITED TO A SINGLE CLIENT ENVIRONMENT. THE INCIDENT LASTED FOR 3 HOURS AND 40 MINUTES ON (B)(6) 2025. DURING THIS TIME, BACKEND SYSTEM SERVICES COULD NOT PROCESS DATA, TEMPORARILY DISRUPTING THE DATA PROCESSING PIPELINE AND POTENTIALLY DELAYING SEPSIS NOTIFICATIONS. THE ISSUE WAS IDENTIFIED AND RESOLVED ON THE SAME DAY, AND CERNER HAS NOT RECEIVED ANY REPORTS OF PATIENT INJURY AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274568 SEPSIS SOFTWARE DEVICE TO AID IN THE PREDICTION OR DIAGNOSIS OF SEPSIS SAK CERNER CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown