ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT)

Additional Manufacturer Narrative

B2, H1: A RISK TO PATIENT HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES. IF THE INCORRECT MERGING OF DATA FROM TWO UNRELATED PATIENT RECORDS IS NOT DETECTED BY THE USER IN THE SUBSEQUENT STEPS OF TREATMENT PREPARATION, AND DATA FROM PATIENT_A IS USED TO MAKE CLINICAL DECISIONS FOR PATIENT_B, THIS COULD, IN A WORST-CASE SCENARIO RESULT IN TREATMENT ERROR OR SERIOUS INJURY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE ISSUE WAS DETECTED BEFORE THE LOCALIZATION AND ANY SURGICAL PROCEDURE WAS PERFORMED ON THE PATIENT. - THERE WAS NO NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE INCORRECT MERGE OF PATIENT RECORDS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 30 MINUTES. - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. H6: ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE ROOT CAUSE OF THE INCORRECT MERGE OF PATIENT RECORDS IS: THE INCORRECT SET UP/CONFIGURATION OF THE PLANNING SERVER (SERVER) SYSTEM BY BRAINLAB SUPPORT AT THIS SITE, NOT ACCORDING TO THE SERVICE DOCUMENTATION. A REVIEW OF THE SITE SET-UP AND LOG FILES PROVIDED BY THE HOSPITAL REVEALED THAT THE BRAINLAB SERVER WAS MISCONFIGURED WITH AN APPLICATION ENTITY TITLE (AET) DESIGNATED TO HANDLE INTRAOPERATIVE (INTRAOP) DATA. THIS LED TO THE SERVER, RECEIVING THE STEREOTAXY DATA FROM THE NON-BRAINLAB CT SCANNER, INTERPRETING IT AS INTRAOP DATA, AND ATTEMPTING TO HANDLE THE DATA AS A NAVIGATION DEVICE, RESULTING IN THE INCORRECT MERGE OF PATIENT RECORDS BY THE BRAINLAB PATIENT SELECTION APPLICATION. IF THE INTRAOP AET HAD NOT BEEN ADDED BY BRAINLAB SUPPORT, THE SYSTEM WOULD HAVE INTERPRETED THE DATA ONLY AS A STANDARD DATASET, CORRECTLY HANDLED IT, AND NO INCORRECT MERGE OF PATIENT RECORDS WOULD HAVE OCCURRED DUE TO THIS ISSUE. IN THIS CASE, THE INCORRECT MERGE OF PATIENT RECORDS WAS RECOGNIZED BY THE USER BEFORE ANY CRITICAL INVASIVE ACTIONS WERE PERFORMED ON THE PATIENT AND THE REMOVAL OF THIS ADDITIONAL AET BY BRAINLAB SUPPORT PREVENTED ANY SUBSEQUENT UNINTENDED MERGES OF PATIENT RECORDS FROM OCCURRING. THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE BRAINLAB DEVICE. CORRESPONDING BRAINLAB MEASURES TO MINIMIZE THIS ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE ALREADY IN PLACE. H7: BRAINLAB INTENDS TO INFORM THE CUSTOMER OF THE INVESTIGATION RESULTS. BRAINLAB PRODUCT SUPPORT SPECIALIST RESPONSIBLE FOR ORIGIN DATA MANAGEMENT REMINDED THE SUPPORT TEAM THAT THE CONFIGURATION THAT LED TO THIS ISSUE IS NOT SUPPORTED, AND THAT THIS MUST BE RE-ITERATED TO THE RELEVANT COLLEAGUES IN THE FIELD.

Description of Event or Problem

A PATIENT RECORD REQUIRED FOR STEREOTACTIC PLANNING COULD NOT BE FOUND ON THE BRAINLAB APPLICATION PATIENT SELECTION 6.2 DURING A FRAME-BASED STEREOTACTIC BIOPSY FOR A SUSPECTED BRAIN TUMOR. AFTER BRIEF TROUBLESHOOTING, IT BECAME CLEAR THAT THE PATIENT RECORD WAS UNINTENTIONALLY MERGED WITH ANOTHER PATIENT RECORD. THE SURGEON RESOLVED THE MERGE WITH SUPPORT FROM BRAINLAB. FURTHER INVESTIGATION BY BRAINLAB UNCOVERED TWO MORE CASES OF INCORRECT PATIENT RECORD MERGES AT THE SAME SITE THAT WERE THEREAFTER RESOLVED. ACCORDING TO THE SURGEON (TREATING CLINICIAN): - THE ISSUE WAS DETECTED BEFORE THE LOCALIZATION AND ANY SURGICAL PROCEDURE WAS PERFORMED ON THE PATIENT. - THERE WAS NO NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE INCORRECT MERGE OF PATIENT RECORDS, ALSO NOT DUE TO SURGERY/ANAESTHESIA PROLONGATION OF CA. 30 MINUTES. - THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED.

Additional Manufacturer Narrative

B2, H1: A RISK TO PATIENT HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES. IF THE INCORRECT MERGING OF DATA FROM TWO UNRELATED PATIENT RECORDS IS NOT DETECTED BY THE USER IN THE SUBSEQUENT STEPS OF TREATMENT PREPARATION, AND DATA FROM PATIENT_A IS USED TO MAKE CLINICAL DECISIONS FOR PATIENT_B, THIS COULD, IN A WORST-CASE SCENARIO RESULT IN TREATMENT ERROR OR SERIOUS INJURY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE ISSUE WAS DETECTED BEFORE THE LOCALIZATION AND ANY SURGICAL PROCEDURE WAS PERFORMED ON THE PATIENT. THERE WAS NO NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE INCORRECT MERGE OF PATIENT RECORDS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 30 MINUTES. THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. A COMPREHENSIVE INVESTIGATION BY BRAINLAB REGARDING THIS SPECIFIC INCIDENT IS CURRENTLY ONGOING AND FINAL CONCLUSIONS ARE PENDING. BRAINLAB PLANS TO ISSUE A FOLLOW-UP REPORT UPON COMPLETION OF THE INVESTIGATION. H6, H7: A COMPREHENSIVE INVESTIGATION BY BRAINLAB REGARDING THIS SPECIFIC INCIDENT IS CURRENTLY ONGOING AND FINAL CONCLUSIONS ARE PENDING. BRAINLAB PLANS TO ISSUE A FOLLOW-UP REPORT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

A PATIENT RECORD REQUIRED FOR STEREOTACTIC PLANNING COULD NOT BE FOUND DURING A FRAME-BASED STEREOTACTIC BIOPSY FOR A SUSPECTED BRAIN TUMOR. AFTER BRIEF TROUBLESHOOTING, IT BECAME CLEAR THAT THE PATIENT RECORD WAS UNINTENTIONALLY MERGED WITH ANOTHER PATIENT RECORD. THE SURGEON RESOLVED THE MERGE WITH SUPPORT FROM BRAINLAB. FURTHER INVESTIGATION BY BRAINLAB UNCOVERED FOUR MORE CASES OF INCORRECT PATIENT RECORD MERGES AT THE SAME SITE THAT WERE THEREAFTER RESOLVED. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE ISSUE WAS DETECTED BEFORE THE LOCALIZATION AND ANY SURGICAL PROCEDURE WAS PERFORMED ON THE PATIENT. THERE WAS NO NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE INCORRECT MERGE OF PATIENT RECORDS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 30 MINUTES. THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. BRAINLAB CONTINUES TO INVESTIGATE THE ISSUE AND WILL CONCLUDE ON CORRESPONDING ACTIONS AS SOON AS POSSIBLE.