MAUDE Adverse Event Report: RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION; RADIATION THERAPY TREATMENT PLANNING SYSTEM

Model Number 11A SP2

Device Problems Use of Incorrect Control/Treatment Settings (1126); Inadequate User Interface (2958)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2022

Event Type  Injury  

Event Description

A raystation customer has reported a mistreatment for one patient.When creating the patient model for a breast patient with a silicone implant, the planner created a material override structure and selected "silicon" as material.The correct density of the silicone polymer used in the implant is close to water (~.94-.98).The pure silicon in the material list has a density of 2.33.The patient was intended to be treated with protons.Luckily, the proton system was down for several days, and the patient was moved to photon treatment for which density has less impact on dose.When they moved back to the proton machine, the error was noted.This clinic's investigation deemed it not to be a misadministration due to the fact that the ptv received proper dose.However, if the mistake were to recur for proton treatment, there could be significant dose deviations so the event is considered reportable by the manufacturer.There was no malfunction.Mistreatment was caused by a user mistake, confusing silicon, si, with silicone polymer.Density is displayed with the material names, so all information needed for correct material assignment is available in the ui.However, user interface improvements will still be considered for future raystation versions.

• Brand Name: RAYSTATION
• Type of Device: RADIATION THERAPY TREATMENT PLANNING SYSTEM
• Manufacturer (Section D): RAYSEARCH LABORATORIES AB (PUBL); eugeniav[?]gen 18; stockholm sweden, SE-11 3 68; SW SE-113 68
• MDR Report Key: 15162489
• MDR Text Key: 297217228
• Report Number: 3010034862-2022-00003
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11A SP2
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other