RAYCARE
Report
- Report Number
- 3010034862-2022-00002
- Event Type
- Injury
- Date Received
- May 3, 2022
- Date of Event
- April 1, 2022
- Report Date
- April 4, 2025
- Manufacturer
- RAYSEARCH LABORATORIES AB (PUBL)
- Product Code
- MUJ
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
RAYCARE CLINICAL DATABASES WERE ACCIDENTALLY DELETED BY RAYSEARCH PERSONNEL WHEN PREPARING FOR THE UPGRADE TO RAYCARE 5B SP1. UNFORTUNATELY, THERE WAS NO RECENT CHECKPOINTED BACKUP AVAILABLE. THE CLINIC WAS GIVEN THE OPTION TO EITHER CONTINUE WITH MISSING DATA OR DO A ROLLBACK TO THE LATEST BACKUP EVEN THOUGH THAT MEANS POTENTIALLY INCONSISTENT DATA. THEY OPTED FOR THE SECOND ALTERNATIVE WHICH MEANS THAT AFTER THE ROLLBACK THEY WILL NEED TO MANUALLY ADD ALL DATA THAT HAS BEEN ENTERED SINCE THE BACKUP. THIS WAS A USE ERROR BY RAYSEARCH PERSONNEL WHICH BECAME SERIOUS DUE TO THAT THE CLINIC WERE NOT DOING PROPER BACKUPS. THERE IS NO ERROR IN THE DEVICE. WARNINGS ARE GIVEN WHEN BACKUPS ARE NOT RUNNING CORRECTLY. HOWEVER, TO SEE THESE WARNINGS, THE CLINIC MUST HAVE REQUIRED MONITORING IN PLACE, WHICH IS COMMUNICATED AS A A "POST REQUISITE" IN IFU. THIS WAS NOT THE CASE AT IRIDIUM LAST YEAR AND WE FILED A SAFETY COMPLAINT TO KEEP TRACK OF OUR ATTEMPTS TO MAKE THE CLINIC RECTIFY THIS. THAT COMPLAINT WAS CLOSED WHEN MONITORING WAS PUT IN PLACE. THE ERROR WAS RESOLVED BY APPLYING A RELEASED SUPPORT TOOL. IN THE SAFETY COMPLAINT MEETING, THE EVENT WAS DETERMINED TO BE REPORTABLE AS IT LED TO LOSS OF CLINICAL DATA IN BOTH RAYCARE AND RAYSTATION. THE SYSTEMS WERE RESTORED THREE WEEKS LATER, A PERIOD WHICH MUST BE RECONSTRUCTED MANUALLY IN TERMS OF DATA AND WORKFLOW PROGRESS FOR BOTH RAYCARE AND RAYSTATION.
RAYCARE CLINICAL DATABASES WERE ACCIDENTALLY DELETED BY RAYSEARCH PERSONNEL WHEN PREPARING FOR THE UPGRADE TO RAYCARE 5B SP1. UNFORTUNATELY, THERE WAS NO RECENT CHECKPOINTED BACKUP AVAILABLE. THE CLINIC WAS GIVEN THE OPTION TO EITHER CONTINUE WITH MISSING DATA OR DO A ROLLBACK TO THE LATEST BACKUP EVEN THOUGH THAT MEANS POTENTIALLY INCONSISTENT DATA. THEY OPTED FOR THE SECOND ALTERNATIVE WHICH MEANS THAT AFTER THE ROLLBACK THEY WILL NEED TO MANUALLY ADD ALL DATA THAT HAS BEEN ENTERED SINCE THE BACKUP. THIS WAS A USE ERROR BY RAYSEARCH PERSONNEL WHICH BECAME SERIOUS DUE TO THAT THE CLINIC WERE NOT DOING PROPER BACKUPS. THERE IS NO ERROR IN THE DEVICE. WARNINGS ARE GIVEN WHEN BACKUPS ARE NOT RUNNING CORRECTLY. HOWEVER, TO SEE THESE WARNINGS, THE CLINIC MUST HAVE REQUIRED MONITORING IN PLACE, WHICH IS COMMUNICATED AS A "POST REQUISITE" IN IFU. THIS WAS NOT THE CASE AT IRIDIUM LAST YEAR AND WE FILED A SAFETY COMPLAINT TO KEEP TRACK OF OUR ATTEMPTS TO MAKE THE CLINIC RECTIFY THIS. THAT COMPLAINT WAS CLOSED WHEN MONITORING WAS PUT IN PLACE. THE ERROR WAS RESOLVED BY APPLYING A RELEASED SUPPORT TOOL. IN THE SAFETY COMPLAINT MEETING, THE EVENT WAS DETERMINED TO BE REPORTABLE AS IT LED TO LOSS OF CLINICAL DATA IN BOTH RAYCARE AND RAYSTATION. THE SYSTEMS WERE RESTORED THREE WEEKS LATER, A PERIOD WHICH MUST BE RECONSTRUCTED MANUALLY IN TERMS OF DATA AND WORKFLOW PROGRESS FOR BOTH RAYCARE AND RAYSTATION.
RAYCARE CLINICAL PATIENT DATABASES AT CUSTOMER SITE WERE ACCIDENTALLY DELETED BY A RSL SERVICE EMPLOYEE. THE ACTION OF DELETING DATABASES IN THE PC ENVIRONMENT WAS INTENDED TO BE PERFORMED ON THE RSL VERIFICATION ENVIRONMENT. THE DELETION OF THE DATABASES WAS DISCOVERED IMMEDIATELY AND A RESTORE WAS PERFORMED TO A NON-CHECKPOINTED BACKUP, WHICH IS NOT SUPPORTED. THIS RESULTED IN AN INCONSISTENT SYSTEM STATE. TO BE ABLE TO RESTORE TO A CONSISTENT STATE, THE SYSTEM MUST BE RESTORED TO A CHECKPOINT OR MINIMALLY TO A POINT IN TIME WHEN THE SYSTEM HAS NO MESSAGES IN FLIGHT. IT WAS EXPECTED THAT THERE WAS A CHECKPOINT TO RESTORE TO FROM THE PREVIOUS NIGHT, BUT THIS PROVED TO NOT BE POSSIBLE DUE TO FAILING CHECKPOINTS. THE CHECKPOINT FAILURE WOULD HAVE BEEN DISCOVERED IF HEALTH MONITORING WAS CORRECTLY USED. FOR UNCLEAR REASONS, THIS WAS NOT THE CASE. BOTH CHECKPOINTING AND HEALTH MONITORING ARE SAFETY RELATED MITIGATION'S WHICH MUST BE MET BY THE CUSTOMER. WHEN ATTEMPTING TO RESTORE BACKUPS FROM A POINT WHERE THE SYSTEM WAS AT REST, IT WAS DISCOVERED THAT CHECKPOINTS CANNOT HAVE BEEN WORKING AT ALL DUE TO A SOFTWARE ERROR IN THE RELEASED PRODUCT. THIS ERROR SHOULD HAVE BEEN DISCOVERED IMMEDIATELY AFTER THE UPGRADE IF MONITORING HAD BEEN IN PLACE AND/OR IF THE CLINIC HAD VERIFIED THAT BACKUPS HAPPENED ACCORDING TO EXPECTATION. THE ERROR WAS RESOLVED BY APPLYING A RELEASED SUPPORT TOOL. IN THE SAFETY COMPLAINT MEETING, THE EVENT WAS DETERMINED TO BE REPORTABLE AS IT LED TO LOSS OF CLINICAL DATA IN BOTH RAYCARE AND RAYSTATION. THE SYSTEMS WERE RESTORED THREE WEEKS LATER, A PERIOD WHICH MUST BE RECONSTRUCTED MANUALLY IN TERMS OF DATA AND WORKFLOW PROGRESS FOR BOTH RAYCARE AND RAYSTATION.
FOLLOW-UP OF REPORT RSA: MDR 3010034862-2022-00002 (B)(4) RC DATABASES LOST AT IRIDIUM. RAYCARE CLINICAL PATIENT DATABASES AT CUSTOMER SITE WERE ACCIDENTALLY DELETED BY A RSL SERVICE EMPLOYEE. THE ACTION OF DELETING DATABASES IN THE PC ENVIRONMENT WAS INTENDED TO BE PERFORMED ON THE RSL VERIFICATION ENVIRONMENT. THE DELETION OF THE DATABASES WAS DISCOVERED IMMEDIATELY AND A RESTORE WAS PERFORMED TO A NON-CHECKPOINTED BACKUP, WHICH IS NOT SUPPORTED. THIS RESULTED IN AN INCONSISTENT SYSTEM STATE. TO BE ABLE TO RESTORE TO A CONSISTENT STATE, THE SYSTEM MUST BE RESTORED TO A CHECKPOINT OR MINIMALLY TO A POINT IN TIME WHEN THE SYSTEM HAS NO MESSAGES IN FLIGHT. IT WAS EXPECTED THAT THERE WAS A CHECKPOINT TO RESTORE TO FROM THE PREVIOUS NIGHT, BUT THIS PROVED TO NOT BE POSSIBLE DUE TO FAILING CHECKPOINTS. THE CHECKPOINT FAILURE WOULD HAVE BEEN DISCOVERED IF HEALTH MONITORING WAS CORRECTLY USED. FOR UNCLEAR REASONS, THIS WAS NOT THE CASE. BOTH CHECKPOINTING AND HEALTH MONITORING ARE SAFETY RELATED MITIGATIONS WHICH MUST BE MET BY THE CUSTOMER. WHEN ATTEMPTING TO RESTORE BACKUPS FROM A POINT WHERE THE SYSTEM WAS AT REST, IT WAS DISCOVERED THAT CHECKPOINTS CANNOT HAVE BEEN WORKING AT ALL DUE TO A SOFTWARE ERROR IN THE RELEASED PRODUCT. THIS ERROR SHOULD HAVE BEEN DISCOVERED IMMEDIATELY AFTER THE UPGRADE IF MONITORING HAD BEEN IN PLACE AND/OR IF THE CLINIC HAD VERIFIED THAT BACKUPS HAPPENED ACCORDING TO EXPECTATION.
FOLLOW-UP OF REPORT RSA: MDR 3010034862-2022-00002 (B)(6) DATABASES LOST AT IRIDIUM. RAYCARE CLINICAL PATIENT DATABASES AT CUSTOMER SITE WERE ACCIDENTALLY DELETED BY A RSL SERVICE EMPLOYEE. THE ACTION OF DELETING DATABASES IN THE PC ENVIRONMENT WAS INTENDED TO BE PERFORMED ON THE RSL VERIFICATION ENVIRONMENT. THE DELETION OF THE DATABASES WAS DISCOVERED IMMEDIATELY AND A RESTORE WAS PERFORMED TO A NON-CHECKPOINTED BACKUP, WHICH IS NOT SUPPORTED. THIS RESULTED IN AN INCONSISTENT SYSTEM STATE. TO BE ABLE TO RESTORE TO A CONSISTENT STATE, THE SYSTEM MUST BE RESTORED TO A CHECKPOINT OR MINIMALLY TO A POINT IN TIME WHEN THE SYSTEM HAS NO MESSAGES IN FLIGHT. IT WAS EXPECTED THAT THERE WAS A CHECKPOINT TO RESTORE TO FROM THE PREVIOUS NIGHT, BUT THIS PROVED TO NOT BE POSSIBLE DUE TO FAILING CHECKPOINTS. THE CHECKPOINT FAILURE WOULD HAVE BEEN DISCOVERED IF HEALTH MONITORING WAS CORRECTLY USED. FOR UNCLEAR REASONS, THIS WAS NOT THE CASE. BOTH CHECKPOINTING AND HEALTH MONITORING ARE SAFETY RELATED MITIGATIONS WHICH MUST BE MET BY THE CUSTOMER. WHEN ATTEMPTING TO RESTORE BACKUPS FROM A POINT WHERE THE SYSTEM WAS AT REST, IT WAS DISCOVERED THAT CHECKPOINTS CANNOT HAVE BEEN WORKING AT ALL DUE TO A SOFTWARE ERROR IN THE RELEASED PRODUCT. THIS ERROR SHOULD HAVE BEEN DISCOVERED IMMEDIATELY AFTER THE UPGRADE IF MONITORING HAD BEEN IN PLACE AND/OR IF THE CLINIC HAD VERIFIED THAT BACKUPS HAPPENED ACCORDING TO EXPECTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2074098 | RAYCARE | RADIATION THERAPY TREATMENT PLANNING SYSTEM | MUJ | RAYSEARCH LABORATORIES AB (PUBL) | RAYCARE 5B SP1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |