MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS IMAGING LABORATORY GMBH ARIA RADIATION THERAPY MANAGEMENT

Model Number 16.1

Device Problems Computer Software Problem (1112); Improper or Incorrect Procedure or Method (2017); Compatibility Problem (2960)

Patient Problem Insufficient Information (4580)

Event Date 01/14/2022

Event Type  malfunction  

Event Description

Per information provided by the customer, a patient was being treated for lung cancer to a dose of 60 gy in 30 fractions using protons on a mevion hyperscan 250i, treatment planning on raystation and with aria 16.1 for recording and verification.On fraction 4, the table position of the setup field was erroneously changed by the user after treatment approval without also updating the treatment position.A total of 3 fractions were treated correctly but 20 were treated incorrectly.This resulted in a treatment significantly inferior to the target with 20 fractions being delivered to normal lung, mediastinum, heart, etc.When the misadministration was noticed, the patient's plan was converted to a photon plan and was delivered using adaptive radiation for 27 fractions since the 20 mis-administered fractions did not touch the tumor.

Manufacturer Narrative

Varian ref (b)(4).Investigation confirmed that when the couch positions are edited after the plan was "treatment approved", if an error message gets displayed by the "treatment preparation" workspace to state a couch position mismatch, the plan can still be loaded on the mevion s250i machine and be treated.This feature to edit the couch position values in "treatment preparation" after a plan was "treatment approved" is described in the "treatment preparation's technical requirements" and "treatment preparation reference guide" documentation.Investigation concludes that the radiation incident occurred because of the combination of the 3 following errors: 1st error: user error.The user considered the setup field couch position wrong after the 3rd fraction was fully delivered and decided to recalculate and change them.The end-user did not modify the couch position of each field (only the setup field was updated, not the treatment fields).This mismatch was introduced despite the fact that when entering the "treatment preparation" workspace, by default, all fields are selected.The user would have had to manually select only the setup field, which would have left all other fields unselected.Since the end-user modified only the setup field couch position, this introduced a mismatch between the setup field and the treatment fields couch positions.The error message displayed by "treatment preparation" did not trigger any reaction from the end-user.Had the end-user noticed the error message and updated the treatment fields couch positions accordingly, no mismatch would have been created.2nd error: application design deficiency: "treatment preparation" workspace displays an error message as soon as the couch position values mismatch.The error does not prevent the end-user from saving the plan, already "treatment approved", with this couch position inconsistency.3rd error: 3rd party treatment machine failure: the mevion s250i proton treatment machine failed to identify this couch position mismatch and to prevent the treatment.A discrepancy report was raised against "treatment preparation" as a corrective action.A 3rd party communication has been initiated with mevion to inform them their machine fails to identify a couch position mismatch in such circumstances.

Event Description

Per information provided by the customer, a patient was being treated for lung cancer to a dose of 60 gy in 30 fractions using protons on a mevion hyperscan 250i, treatment planning on raystation and with aria 16.1 for recording and verification.On fraction 4, the table position of the setup field was erroneously changed by the user after treatment approval without also updating the treatment position.A total of 3 fractions were treated correctly but 20 were treated incorrectly.This resulted in a treatment significantly inferior to the target with 20 fractions being delivered to normal lung, mediastinum, heart, etc.When the misadministration was noticed, the patient's plan was converted to a photon plan and was delivered using adaptive radiation for 27 fractions since the 20 mis-administered fractions did not touch the tumor.

Manufacturer Narrative

Fsca filed.No further medwatch follow ups will be provided.Note: udi-di number has been updated.

• Brand Name: ARIA RADIATION THERAPY MANAGEMENT
• Type of Device: ARIA RADIATION THERAPY MANAGEMENT
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS IMAGING LABORATORY GMBH; taefernstrasse 7; daettwil, argovia aargau
• Manufacturer Contact: k. semone ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 13543300
• MDR Text Key: 288476836
• Report Number: 3003094912-2022-00002
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00856100006165
• UDI-Public: 00856100006165
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K173838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 16.1
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2022
• Removal/Correction Number: NC-2022-00047
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female