BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEPSIS

    MDR report key: 22860882 · Received August 21, 2025

    Report

    Report Number
    1931259-2025-00014
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 21, 2025
    Manufacturer
    CERNER CORPORATION
    Product Code
    SAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS RESOLVED BY RESTORING THE SERVICE, WHICH REINSTATED NORMAL DATA INGESTION, PROCESSING, AND THE TIMELY GENERATION OF SEPSIS NOTIFICATIONS. ORACLE CONSIDERS THIS INVESTIGATION CLOSED. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    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. SEPSIS NOTIFICATIONS WERE DELAYED DUE TO A SERVICE AUTHENTICATION ISSUE CRITICAL FOR THE DATA INGESTION PROCESS. THIS SERVICE, WHICH RELIES ON AMAZON WEB SERVICES (AWS) AS ITS CLOUD PROVIDER, WAS AFFECTED WHEN AWS INTRODUCED NEW SECURITY RULES THAT HAD A GLOBAL IMPACT AND INADVERTENTLY BLOCKED CERTAIN VALID NETWORK COMMUNICATIONS. AS A RESULT, SEPSIS NOTIFICATIONS WERE DELAYED BY APPROXIMATELY 14 HOURS ON (B)(6) 2025. CERNER NOTIFIED CUSTOMERS SOON AFTER THE ISSUE BEGAN ON (B)(6) 2025. THE ISSUE HAS SINCE BEEN RESOLVED, AND ALL SEPSIS NOTIFICATIONS ARE NOW OPERATING AS EXPECTED. 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
    443267 SEPSIS SOFTWARE SAK CERNER CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown