SEPSIS

Additional Manufacturer Narrative

THE ISSUE HAS BEEN FULLY RESOLVED AND AN INTERNAL INVESTIGATION IS ONGOING.

Description of Event or Problem

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 MARCH 5, 2026, A HARDWARE-RELATED ISSUE OCCURRED WITHIN THE SYSTEM SUPPORTING THE DEVICE. ONE SYSTEM COMPONENT EXPERIENCED REDUCED PERFORMANCE, RESULTING IN SLOWER DATA PROCESSING AND A BUILDUP OF PENDING INFORMATION. WHILE THE SYSTEM WAS RECOVERING, A SECOND COMPONENT EXPERIENCED A SIMILAR HARDWARE-RELATED PERFORMANCE ISSUE. BECAUSE ONLY ONE COMPONENT COULD BE ADDRESSED AT A TIME, THE SECOND COMPONENT CONTINUED OPERATING WITH REDUCED PERFORMANCE FOR A LONGER PERIOD. THE COMBINED IMPACT RESULTED IN CONTINUED SLOW SYSTEM PERFORMANCE, INCREASED BACKLOG, AND DELAYS IN DATA PROCESSING. THESE DELAYS AFFECTED SYSTEM FUNCTIONS THAT RELY ON TIMELY DATA PROCESSING AND RESULTED IN DELAYED SEPSIS NOTIFICATIONS DUE TO REDUCED SYSTEM PERFORMANCE. STANDARD HARDWARE REMEDIATION PROCEDURES WERE COMPLETED, AFTER WHICH SYSTEM PERFORMANCE RETURNED TO NORMAL AND THE BACKLOG WAS CLEARED. THE TOTAL DURATION OF THE EVENT WAS APPROXIMATELY 3 HOURS AND 5 MINUTES, WITH A MAXIMUM OBSERVED DELAY OF APPROXIMATELY 69 MINUTES. NO CUSTOMER COMPLAINTS, ADVERSE EVENTS, OR PATIENT HARM HAVE BEEN REPORTED IN RELATION TO THIS EVENT.