PINNACLE3 SMART ENTERPRISE SERVER

Description of Event or Problem

IT WAS REPORTED TO PHILIPS THAT INCORRECT IMAGE DATA WAS USED TO CREATE A TREATMENT PLAN. WHEN EXPORTING THE TREATMENT PLAN THE ONCOLOGY INFORMATION SYSTEM (OIS) WARNED THE USER THE IMAGES WERE ALREADY IN USE BY A DIFFERENT PATIENT. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

Description of Event or Problem

PHILIPS INVESTIGATION OF THIS ISSUE IS ONGOING. NO NEW INFORMATION HAS BEEN RECEIVED AND THE INVESTIGATION IS STILL PENDING COMPLETION, THEREFORE THE DATE DUE WILL BE UPDATED TO 06-JUL-2024.

Description of Event or Problem

IT WAS REPORTED TO PHILIPS THAT INCORRECT IMAGE DATA WAS USED TO CREATE A TREATMENT PLAN. WHEN EXPORTING THE TREATMENT PLAN THE ONCOLOGY INFORMATION SYSTEM (OIS) WARNED THE USER THE IMAGES WERE ALREADY IN USE BY A DIFFERENT PATIENT. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED.

Additional Manufacturer Narrative

THIS WAS DISCOVERED TO BE A RARE SEQUENCE OF EVENTS WHERE THE CUSTOMER WAS MISUSING THE PINNACLE PRODUCT. A SERIES OF MEETINGS WAS CONDUCTED WITH CLINICAL SUBJECT MATTER EXPERTS (SMES) AS WELL AS THE PHILIPS MEDICAL AFFAIRS MANAGER TO DISCUSS THE EVENTS AROUND THIS COMPLAINT. THIS REVIEW FOUND THAT THE EVENTS OUTLINED IN THIS COMPLAINT WERE NOT CLINICALLY FORESEEABLE TO HAVE A POTENTIAL SAFETY RISK. PINNACLE IS A TREATMENT PLANNING SOFTWARE AND STANDARD PRACTICE FOR THE USE OF THIS SYSTEM PROVIDES A MULTI-LEVEL VERIFICATION PROCESS TO ENSURE THAT PATIENT DATA IS CORRECT DURING THE PLANNING PROCESS PRIOR TO ANY TREATMENT. THE SEQUENCE OF EVENTS REQUIRED FOR THIS TO BE A HAZARDOUS SITUATION INVOLVED THE MANUAL CREATION OF FOLDERS WITHIN THE PINNACLE SYSTEM AND MANUALLY PLACING COMPUTED TOMOGRAPHY (CT) DATA INTO THE PINNACLE SOFTWARE WHICH IS OUTSIDE OF THE DESIGNED CLINICAL USE OF THE PRODUCT. IF A USER DOES NOT SEE THE EXPECTED DATA/FOLDERS IMPORTED INTO PINNACLE, THE STANDARD PROCESS WOULD BE TO INVESTIGATE THE REASON THE INFORMATION IS MISSING AND TRY TO REIMPORT THE DATA, NOT MANUALLY CREATE FOLDERS AND MANUALLY ENTER DATA INTO THE FOLDERS. EVEN IN THIS EVENT WHERE THE CUSTOMER MANUALLY CREATED THE FOLDER AND MANUALLY COPIED A CT DATA SET INTO THE SYSTEM, THE DICOM (DIGITAL IMAGING AND COMMUNICATION IN MEDICINE) MUST VERIFY THE CONTAINERS DATA TO THE CORRECT UNIQUE IDENTIFIER (UID). THE CONCLUSION OF THE CLINICAL SMES IS THAT THIS CONSTITUTES MISUSE OF THE PINNACLE PRODUCT AND IS NOT CLINICALLY FORESEEABLE TO BE A POTENTIAL SAFETY RISK FOR A PATIENT. THE VARIOUS SYSTEM VERIFICATIONS OUTLINED IN DICOM AS WELL QUALITY CHECKS OUTLINED IN TASK GROUP 40 (TG40) - COMPREHENSIVE QUALITY ASSURANCE FOR RADIATION ONCOLOGY AND TASK GROUP 50 (TG50) - QUALITY ASSURANCE FOR CLINICAL RADIOTHERAPY TREATMENT PLANNING WOULD DETECT THE ISSUE DURING THE PLANNING PROCESS AND TREATMENT WOULD NOT OCCUR. BASED ON THE AVAILABLE INFORMATION AND THE INVESTIGATION PERFORMED, THIS ISSUE WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR.