SYNGO WORKFLOW SLR

Additional Manufacturer Narrative

THE ISSUE WAS INVESTIGATED BY SIEMENS EXPERTS AND THE ROOT CAUSE FOR THE REPORTED ISSUE WAS IDENTIFIED AS FOLLOW. WHEN A NEW ORDER ARRIVES AND THE HIS-RIS (HOSPITAL INFORMATION SYSTEM) INTERFACE JOB INSERTS A ROW INTO THE "VISIT_ORDER" TABLE. BEFORE ADDITIONAL ROWS CAN BE INSERTED BY HIS-RIS INTO THE "VISIT_ACTIVITY" AND "VISIT_ACTIVITY_INFO" TABLES, THE CURSOR THAT DELETES ROWS FROM "VISIT_ORDER" TABLE WITHOUT "CORRESPONDING VISIT_ACTIVITY/VISIT_ACTIVITY_INFO" RUNS AND DELETES JUST-INSERTED ROWS IN THE "VISIT_ORDER" TABLE. THE REPORTED ISSUE ONLY MAY OCCUR ON SYNGO WORKFLOW SLR SYSTEMS RUNNING ON THE VB10C AND VB20A SOFTWARE VERSION. IN MAY 2015 SIEMENS INFORMED ALL POTENTIALLY AFFECTED USERS ABOUT THE REPORTED ISSUE VIA A CUSTOMER SAFETY ADVISORY NOTICE (CSAN). THE CSAN WAS DISTRIBUTED VIA AN UPDATE INSTRUCTION SY037/15/S AND REPORTED TO FDA UNDER C&R REPORT # 2240869-05/08/15-0013-C (Z-1704-2015). SIEMENS IS DEVELOPING A FIELD MODIFICATION TO RESOLVE THIS MATTER.

Description of Event or Problem

SIEMENS BECAME AWARE OF AN EVENT WHEN THE "VISIT_ORDER ROW" FOR THE ORDER WAS FOUND TO BE MISSING EVEN THOUGH THE "HISRISI_PUT_ORD" STORED PROCEDURE WAS PERFORMED. MEANING NO ORDER WOULD BE SCHEDULED AS DESIRED FOR THIS TRANSACTION AND WILL GET LOST WITHOUT ANY INDICATION TO THE USER. THIS MAY POTENTIALLY LEAD TO DELAY OF DIAGNOSIS AND REQUIRED TREATMENT. HOWEVER THE PROBABILITY OF SUCH OCCURRENCE LEADING TO HARM IS EXTREMELY LOW. IN THE WORST CASE SCENARIO A HIGHER PROBABILITY OF POTENTIAL HARM EXISTS FOR EMERGENCY DEPARTMENTS WITH AN ELECTRONIC ORDER WORKFLOW AND PATIENTS WITH POTENTIAL BRAIN BLEEDING.