RAYSTATION 6

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-05-28 for RAYSTATION 6 manufactured by Raysearch Laboratories Ab (publ).

Event Text Entries

[146276088] This incident is reported late as the initial evaluation was that it was a minor issue, not requiring reporting. However, final review of the incident report concluded that there may be non-remote risk of harm if the use error were to recur and it was decided to file a report. A cbct scan was imported for dose re-evaluation of an existing plan. To compensate for the limited field-of-view, a region-of-interest (roi) "external-field-of-view" with a density override was created on the cbct. This roi was equal to the external roi of the cbct minus the "field-of-view" roi and had a density override of 1g/cm?. Using the cbct, a re-evaluation of the dose was done in plan evaluation. Based on this, it was decided to create a new treatment plan for the patient using a new planning ct. The new planning ct was imported, and a new plan was created. In raystation, the structure-set is shared between all image sets for a patient case. The "external-field-of-view" therefor existed also on the new planning ct. Since no "field-of-view" roi was present on the new ct, the "external-field-of-view" roi was equal to the "external" roi with a density override of 1g/cm? , so dose calculation was performed using a homogeneous density instead of accounting for the reduced density in the lungs. The plan was optimized on the new ct with the unintended density override. The unintended density override was not detected during plan evaluation or approval, and the patient was treated using this treatment plan. The error was detected after one fraction. The effect of the density override on the plan only resulted in a minor increase in dose on the organs at risk and a 7% increase of max dose inside the gtv. No harm to the patient is expected. The incident was reported by the clinic as a use error. Raystation functions as intended. The clinic has received assistance in modifying the plan report to better highlight density overrides. Usability improvements will be considered for future product versions.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3007774465-2019-00001
• MDR Report Key: 8646821
• Report Source: FOREIGN,HEALTH PROFESSIONAL,U
• Date Received: 2019-05-28
• Date of Report: 2019-05-27
• Date of Event: 2019-03-15
• Date Mfgr Received: 2019-03-15
• Device Manufacturer Date: 2017-06-01
• Date Added to Maude: 2019-05-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. DAVID HEDFORS
• Manufacturer Street: PO BOX 3297
• Manufacturer City: STOCKHOLM, 10365
• Manufacturer Country: SW
• Manufacturer Postal: 10365
• Manufacturer G1: RAYSEARCH LABORATORIES AB (PUBL)
• Manufacturer Street: SVEAVAGEN 44
• Manufacturer City: STOCKHOLM, 11134
• Manufacturer Country: SW
• Manufacturer Postal Code: 11134
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RAYSTATION
• Generic Name: RADIATION THERAPY TREATMENT PLANNING SYSTEM
• Product Code: MUJ
• Date Received: 2019-05-28
• Model Number: 6
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RAYSEARCH LABORATORIES AB (PUBL)
• Manufacturer Address: SVEAVAGEN 44 STOCKHOLM, 11134 SW 11134

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-05-28