SEPSIS

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 2, A DATA INGESTION COMPONENT SUPPORTING THE SEPSIS SOLUTION BECAME NON-RESPONSIVE. THE INGESTION PROCESS DID NOT TERMINATE, AND AUTOMATED MONITORING AND RESTART CONTROLS DID NOT TRIGGER, RESULTING IN A PROCESSING BACKLOG AND DELAYED DOWNSTREAM PROCESSING. AS A RESULT, SEPSIS NOTIFICATIONS FOR AFFECTED CUSTOMERS MAY HAVE BEEN DELAYED BY UP TO APPROXIMATELY 85 MINUTES DURING THE EVENT WINDOW. THE ISSUE WAS IDENTIFIED BY THE CERNER TEAM, THE AFFECTED PROCESS WAS MANUALLY RECYCLED, AND THE BACKLOG WAS CLEARED. NORMAL PROCESSING WAS RESTORED AND THE CONDITION IS CONSIDERED RESOLVED. A NOTIFICATION WAS ISSUED TO IMPACTED CUSTOMERS. NO CUSTOMER REPORTS OF RELATED PRODUCT ISSUES, ADVERSE EVENTS, OR PATIENT HARM HAVE BEEN RECEIVED IN CONNECTION WITH THIS INCIDENT.

Additional Manufacturer Narrative

THE ISSUE HAS BEEN FULLY RESOLVED, AND NO REPORTS OF PATIENT HARM WERE RECEIVED. A NOTIFICATION WAS SENT TO THE AFFECTED CUSTOMERS. CERNER'S INTERNAL INVESTIGATION IS ONGOING.