RAYCARE

Additional Manufacturer Narrative

THERE HAS BEEN NO ADVERSE EVENT. A SOFTWARE IMPLEMENTATION ERROR HAS BEEN IDENTIFIED. IN CASE THE APPOINTMENT IS RESCHEDULED AND THE OPENED TREATMENT IS DELIVERED TO THE PATIENT; THE PATIENT RECEIVES AN UNINTENDED TREATMENT FRACTION. SCENARIO 1: PATIENT ARRIVES IN THE CLINIC AND HAS A RADIATION ONCOLOGIST CONSULTATION BEFORE THE TREATMENT SESSION. THE RADIATION ONCOLOGIST DECIDES THAT THE PATIENT SHOULD NOT BE TREATED TODAY DUE TO THE PATIENT'S HEALTH SITUATION. THE THERAPIST ALREADY OPENS THE SESSION AWAITING THE PATIENT TO COME FOR TREATMENT. THE TREATMENT APPOINTMENT IS RESCHEDULED FROM TODAY TO A LATER DAY. THE THERAPIST IS NOT INFORMED OF THIS CHANGE. THE PATIENT IS IN RADIOTHERAPY DEPARTMENT AND IS ASKED TO GO TO THE TREATMENT DELIVERY DEVICE BY THE THERAPIST. HARM: DELIVERY OF CORRECT PLAN ON UNINTENDED DATE OR TIME LEADING TO UNEXPECTED TOXICITIES FOR THE PATIENT SERIOUS. SCENARIO 2: PATIENT ARRIVES IN THE CLINIC; THE RADIATION ONCOLOGIST REVIEWS THE LAB VALUES AND DECIDES THAT THE PATIENT CANNOT BE TREATED TODAY DUE TO THE PATIENT'S HEALTH SITUATION. THE PATIENT IS NOT SEEN IN THIS SCENARIO BY THE RADIATION ONCOLOGIST AND IS NOT AWARE OF THE DECISION. THE THERAPIST ALREADY OPENS THE SESSION AWAITING THE PATIENT TO COME FOR TREATMENT. THE TREATMENT APPOINTMENT IS RESCHEDULED FROM TODAY TO A LATER DAY. THE THERAPIST IS NOT INFORMED OF THIS CHANGE. THE PATIENT IS IN RADIOTHERAPY DEPARTMENT AND IS ASKED TO GO TO THE TREATMENT DELIVERY DEVICE BY THE THERAPIST. HARM: DELIVERY OF CORRECT PLAN ON UNINTENDED DATE OR TIME LEADING TO UNEXPECTED TOXICITIES FOR THE PATIENT - SERIOUS SCENARIO 3: IF IT IS DECIDED THAT A BEAM SET MUST BE ADAPTED WITHOUT DELIVERING ANY FURTHER FRACTIONS WITH THE CURRENT BEAM SET, THE USER WILL RESCHEDULE THE APPOINTMENT TO A LATER DAY WITHOUT NOTIFYING THE THERAPISTS AT THE TREATMENT DELIVERY DEVICE. AS A PRECAUTION, THE USER COULD UNAPPROVED THE TREATMENT COURSE OR THE UNAPPROVED THE BEAM SET FOR DELIVERY (CONFIGURABLE TO BE USED). IN CASE THAT THE USER FOLLOWS A DIFFERENT PROCEDURE AND ONLY PERFORMS THESE STEPS AT A LATER TIME, THE USER DELIVERS INCORRECT TREATMENT PLAN ON THE INCORRECT TIME. HARM: DELIVERY OF THE UNINTENDED TREATMENT PLAN ON UNINTENDED DATE OR TIME LEADING TO UNEXPECTED TOXICITIES FOR THE PATIENT - SERIOUS.

Description of Event or Problem

THE ISSUE WAS FOUND INTERNALLY AT RAYSEARCH. THE ISSUE OCCURS WHEN A TREATMENT APPOINTMENT IS RESCHEDULED WHILE THE TREATMENT SESSION HAS BEEN OPENED CAUSING A PATIENT TO POTENTIALLY RECEIVE TREATMENT EVEN WHEN NO VALID SCHEDULED APPOINTMENT EXISTS NOT FOLLOWING THE INTENDED TREATMENT FOR THE PATIENT. THIS SCENARIO CAN OCCUR WHEN THE TREATMENT PREPARATION HAS STARTED AND THERE IS A DECISION MADE AT THE SAME TIME TO RESCHEDULE THE BOOKED TREATMENT APPOINTMENT. THE ISSUE MANIFESTS DIFFERENTLY FOR THE DIFFERENT TREATMENT APPLICATIONS: RAYTREAT: AN INFORMATION MESSAGE IS DISPLAYED TO THE USER WHEN THE APPOINTMENT IS NOT SCHEDULED ON THE CURRENT DAY. TECHNICALLY, RAYTREAT WILL TRY TO BLOCK THE TREATMENT DELIVERY ON THE TREATMENT DELIVERY DEVICE WHEN THE SESSION HAS NOT BEEN STARTED ON THE TREATMENT DELIVERY CONSOLE. WHEN THE SESSION HAS BEEN LOADED ON THE TREATMENT DELIVERY CONSOLE, THE TECHNICAL BLOCK CANNOT BE PERFORMED ANYMORE. A WARNING IS ADDED TO THE IFU FOR THE ACCURAY INTEGRATION SINCE THE TECHNICAL IMPLEMENTATION IS NOT FOLLOWED BY ACCURAY. RAYCARE TREATMENT APPLICATION: THE USER IS NOT INFORMED WHEN THE TREATMENT SESSION IS OPENED AND THE TREATMENT APPOINTMENT IS RESCHEDULED. NO TECHNICAL BLOCK EXISTS. IT IS POSSIBLE TO PROCEED WITH THE OPENED TREATMENT SESSION IN AN UNINTENDED STATE. FORESEEABLE SEQUENCE OF EVENT: PATIENT ARRIVES AT THE CLINIC, HAS A DOCTOR'S APPOINTMENT BEFORE THE TREATMENT SESSION DOCTOR DECIDES NO TREATMENT TODAY AS OF THE PATIENT'S HEALTH SITUATION. THERAPIST HAS ALREADY OPENED THE SESSION AWAITING THE PATIENT TO COME FOR TREATMENT. DOCTOR OR ANY ASSISTANT RESCHEDULES THE SESSION FROM TODAY TO ANOTHER DAY. PATIENT IS IN CLINIC AND WILL BE APPROACHED BY THE RADIATION THERAPIST FOR TREATMENT. PATIENT WILL RECEIVE PLANNED TREATMENT ON AN UNINTENDED TIME.