RAYSTATION 5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-19 for RAYSTATION 5 manufactured by Raysearch Laboratories Ab (publ).

Event Text Entries

[98169309] Report on use error leading to incorrect radiotherapy treatment volume for one a patient. The user did not understand the consequences of the center beam in field functionality when beams share an isocenter and the target area defined by the physician was unintentionally modified. Although the modified apertures were clearly displayed for review and approval, it was not noticed that they were not irradiating the intended target. Intended treatment was 8gy x 1fx to vertebrae c6-th2 using two opposed fields. The intended target area was defined by resident and oncologist by defining a treatment beam a with aperture using the vsim workspace. The rtt then created an opposed field b. There was no delineated volume defining the intended target, only the aperture. It was noticed that the isocenter was outside the field opening. Therefore, the "center beam in field" functionality was used on beam a to move the isocenter to the center of the field while keeping the aperture at the intended target area. The resident reviewed field a and verified that the field opening was still as intended. Since field b used the same isocenter as a, the isocenter for b was also automatically moved. The standard behavior when moving an isocenter was automatically used for this beam, i. E. The field opening moved with the isocenter, to outside the intended target area. It was noticed that the isocenter was still outside the b field opening. Therefore, center beam in field was used on beam b without the user realizing that field b had moved away from the intended target area. The isocenter was then moved to the center of the incorrect field opening. Since beam a was not selected for "center beam in field", the field opening was moved with the isocenter, resulting in the same incorrect irradiated area as for beam b. The incorrect field openings were not noticed before or at delivery. As a result, the patient was irradiated on th 1-4 (instead of c6-th2). At staff meeting for case review, the resident reported that the irradiated area was not what had been originally defined in vsim. Patient was treated again a week later with 8gy x 1fx, completion field for c6-th1.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3007774465-2018-00001
• MDR Report Key: 7204944
• Date Received: 2018-01-19
• Date of Report: 2018-01-18
• Date of Event: 2017-11-15
• Date Mfgr Received: 2017-12-19
• Device Manufacturer Date: 2016-04-20
• Date Added to Maude: 2018-01-19
• 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: SVEAV[?]GEN 44
• Manufacturer City: STOCKHOLM, 11134
• Manufacturer Country: SW
• Manufacturer Postal: 11134
• Manufacturer G1: RAYSEARCH LABORATORIES AB (PUBL)
• Manufacturer Street: SVEAV[?]GEN 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: 0

Device Details

• Brand Name: RAYSTATION
• Generic Name: RADIATION THERAPY TREATMENT PLANNING SYSTEM
• Product Code: MUJ
• Date Received: 2018-01-19
• Model Number: 5
• 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: SVEAV[?]GEN 44 STOCKHOLM, 11134 SW 11134

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-01-19