BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEPSIS

    MDR report key: 22558649 · Received July 21, 2025

    Report

    Report Number
    1931259-2025-00012
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 24, 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

    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, OBSERVER SERVICES BECAME UNRESPONSIVE WHILE PROCESSING AN UNUSUALLY LARGE CLIENT-GENERATED DATA LOAD, RESULTING IN DELAYED SEPSIS NOTIFICATIONS FOR APPROXIMATELY SIX HOURS. 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.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, CERNER'S INTERNAL MONITORING SYSTEMS DETECTED A DELAY IN THE TRANSMISSION OF SEPSIS NOTIFICATIONS, TRIGGERING AN IMMEDIATE INVESTIGATION. THE CAUSE OF THE INCIDENT IS DUE TO A BACKEND SYSTEM ISSUE, WHERE OBSERVER SERVICES BECAME UNRESPONSIVE WHILE ATTEMPTING TO PROCESS AN UNUSUALLY LARGE DATA LOAD GENERATED BY THE CLIENT. THE ISSUE WAS MITIGATED BY RECYCLING THE AFFECTED SERVICES, WHICH SUCCESSFULLY CLEARED THE BACKLOG AND RESTORED NORMAL DATA PROCESSING OPERATIONS. THE INCIDENT HAS BEEN SUCCESSFULLY RESOLVED. CERNER IS INVESTIGATING THE ISSUE OF THE OBSERVER SERVICES BECOMING UNRESPONSIVE.

    Description of Event or Problem · 0

    THE SOFTWARE PRODUCT MENTIONED IN THIS MEDWATCH REPORT MAY NOT BE A MEDICAL DEVICE; HOWEVER, CERNER HAS CHOSEN TO FILE THIS MEDWATCH REPORT TO VOLUNTARILY NOTIFY THE FDA OF THE RESOLUTION OF A MALFUNCTION ASSOCIATED WITH THIS SOFTWARE PRODUCT. THIS ISSUE PERTAINED TO THE CERNER MILLENNIUM SEPSIS MODULE AND AFFECTED THE CLOUD-BASED SOLUTION. ON (B)(6) 2025, A TEMPORARY DISRUPTION OCCURRED IN A SINGLE CLIENT ENVIRONMENT, LASTING APPROXIMATELY SIX HOURS. DURING THIS PERIOD, BACKEND SYSTEM SERVICES WERE UNABLE TO PROCESS A LARGE DATA LOAD, WHICH LED TO A DELAY IN THE DATA PROCESSING PIPELINE. AS A RESULT, THE GENERATION OF SEPSIS NOTIFICATIONS MAY HAVE BEEN DELAYED WITHIN THE AFFECTED TIMEFRAME. THE ISSUE WAS IDENTIFIED AND RESOLVED ON THE SAME DAY. CERNER HAS NOT RECEIVED COMMUNICATION ON ANY ADVERSE PATIENT EVENTS AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938247 SEPSIS SOFTWARE SAK CERNER CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown