BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEPSIS

    MDR report key: 24701748 · Received March 26, 2026

    Report

    Report Number
    1931259-2025-00008
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Report Date
    March 26, 2026
    Product Code
    SAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP MDR IS SUBMITTED TO CORRECT THE INITIAL MDR REPORT NUMBER LISTED AS 1193125-2025-00008. THE CORRECT REPORT NUMBER IS 193125-2025-00008. CERNER COMPLETED ITS INVESTIGATION OF THIS EVENT (INITIAL MDR 1193125-2025-00008) 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 1 HOUR AND 20 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

    THIS MDR IS SUBMITTED TO CORRECT THE INITIAL MDR REPORT NUMBER LISTED AS 1193125-2025-00008. THE CORRECT REPORT NUMBER IS 193125-2025-00008. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757134 SEPSIS SOFTWARE SAK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown