BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEPSIS

    MDR report key: 25093518 · Received May 6, 2026

    Report

    Report Number
    1931259-2026-00010
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 6, 2026
    Manufacturer
    CERNER CORPORATION
    Product Code
    SAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 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.

    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. ON (B)(6) TWO CUSTOMERS EXPERIENCED PROCESSING DELAYS WITHIN THE SHARED ENVIRONMENT DUE TO INCREASED SYSTEM LOAD. FOR BAPTIST HEALTH, AL, DELAYS WERE CAUSED BY EXCESSIVE DATA INGESTION RESULTING FROM DUPLICATE CRAWLERS OPERATING SIMULTANEOUSLY WITHIN THE CUSTOMER ENVIRONMENT. A LEGACY CRAWLER REMAINED ACTIVE FOLLOWING A PRIOR MIGRATION AND CONTINUED RUNNING IN PARALLEL WITH THE INTENDED CRAWLER, GENERATING DATA VOLUMES THAT EXCEEDED PROCESSING CAPACITY AND LED TO SYSTEM RESOURCE SATURATION. THE ISSUE WAS RESOLVED BY IDENTIFYING AND DISABLING THE DUPLICATE CRAWLER, AFTER WHICH BACKLOG PROCESSING COMPLETED AND NORMAL OPERATIONS RESUMED. THE LONGEST OBSERVED DELAY WAS APPROXIMATELY 4 HOURS AND 6 MINUTES, WITH A TOTAL INCIDENT DURATION OF APPROXIMATELY 4 HOURS AND 48 MINUTES. FOR USC UNITERSITY HOSPITAL, CA , DELAYS OCCURRED WHILE SYSTEM RESOURCES WERE HEAVILY UTILIZED DURING RECOVERY EFFORTS FOR THE BAPTIST HEALTH. THE ELEVATED RESOURCE CONSUMPTION WITHIN THE SHARED ENVIRONMENT REDUCED PROCESSING PERFORMANCE, RESULTING IN DELAYED PROCESSING FOR USC UNITERSITY HOSPITAL UNTIL SYSTEM PERFORMANCE RETURNED TO NORMAL. THE LONGEST OBSERVED DELAY FOR USC UNITERSITY HOSPITAL WAS APPROXIMATELY 1 HOUR AND 51 MINUTES, WITH A TOTAL INCIDENT DURATION OF APPROXIMATELY 1 HOUR AND 46 MINUTES. THE AFFECTED CUSTOMER WAS NOTIFIED AT THE TIME OF THE EVENT. THE ISSUE HAS BEEN FULLY RESOLVED, AND NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT HAVE BEEN RECEIVED BY CERNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308938 SEPSIS SOFTWARE SAK CERNER CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown