BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEPSIS

    MDR report key: 23407985 · Received October 28, 2025

    Report

    Report Number
    1931259-2025-00017
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 3, 2025
    Report Date
    February 26, 2026
    Manufacturer
    CERNER CORPORATION
    Product Code
    SAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, CERNER'S INTERNAL MONITORING SYSTEMS IDENTIFIED A PROBLEM THAT CAUSED DELAYS IN SENDING SEPSIS NOTIFICATIONS, PROMPTING AN IMMEDIATE INVESTIGATION. THE ISSUE HAS BEEN SUCCESSFULLY RESOLVED. A COMPREHENSIVE INVESTIGATION IS UNDERWAY TO DETERMINE THE UNDERLYING ROOT CAUSE. CERNER WILL PROVIDE A FOLLOW-UP REPORT AT THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CERNER HAS COMPLETED ITS INTERNAL INVESTIGATION OF THE INCIDENT AND DETERMINED THAT THE ROOT CAUSE WAS IDENTIFIED AS A SOFTWARE DEFECT IN INPUT VALIDATION LOGIC THAT DID NOT ACCOUNT FOR WIDE WHITESPACE CHARACTERS, RESULTING IN A PROCESSING FAILURE. THE ISSUE WAS ULTIMATELY RESOLVED BY REMOVING INVALID RECORDS FROM THE DATA PROCESSING PIPELINE. ADDITIONALLY, A SOLUTION CHANGE WAS LOGGED AND IMPLEMENTED TO PREVENT RECURRENCE. CERNER 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. ON (B)(6) 2025 AT APPROXIMATELY 9:45 AM CST, A CUSTOMER'S SEPSIS NOTIFICATIONS STOPPED PROCESSING, ALTHOUGH DATA INGESTION CONTINUED AS NORMAL. THIS INTERRUPTION EXCLUSIVELY AFFECTED A SINGLE CUSTOMER AND RESULTED IN A DELAY IN NOTIFICATION PROCESSING FOR 1 HOUR AND 29 MINUTES. THE ISSUE WAS SUCCESSFULLY RESOLVED BY REMOVING INVALID RECORDS FROM THE DATA PROCESSING PIPELINE. ANALYSIS OF THE AFFECTED RECORDS CONFIRMED THAT NO SEPSIS NOTIFICATIONS WOULD HAVE BEEN GENERATED DURING THE OUTAGE. CERNER HAS NOT RECEIVED ANY REPORTS OF PATIENT INJURY RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840739 SEPSIS SOFTWARE DEVICE TO AID IN THE PREDICTION OR DIAGNOSIS OF SEPSIS SAK CERNER CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown