MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS ECLIPSE; TREATMENT PLANNING SYSTEM

Model Number	16.1
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Varian reference (b)(4).Customer confirmed that due to this use error seven patients received incorrect treatment.Patients received higher dose than intended.For two patients it was determined no serious injury occurred, for the remaining five patients it is unknown whether serious injury occurred.Eclipse is working as intended.It is confirmed that the incorrect calibration values in the ct calibration curve for the ct somatom confidence was caused by use error.Varian documentation states that verification of the calibration curve entries is the responsibility of the customer.The documentation provides a method for the customer to verify the configuration of the ct calibration curve.
Event or Problem Description
The customer reported that on (b)(6) 2020 a plan that was calculated in eclipse had an unexpected dose distribution with high dose extending outside the ptv and towards the patient skin.The patient had not been treated.The issue was reproducible at the customer site for the same patient.The patient data was retrieved from the customer site and tested with varian standard beam model and algorithms, and same dose constraints, but the issue was not reproducible.After some troubleshooting by varian service/helpdesk, it was found that the issue was due to the electron calibration curve that was incorrectly defined as absolute density, instead of as relative to water density.No injury or death was reported.

• Brand Name: ECLIPSE
• Common Device Name: TREATMENT PLANNING SYSTEM
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 911 hansen way; palo alto CA 94304 1028
• MDR Report Key: 10852382
• Report Number: 3003793371-2020-00001
• Device Sequence Number: 19705527
• Product Code: MUJ
• UDI-Device Identifier: 00855141006080
• UDI-Public: (01)00855141006080(11)200529(10)1601000
• Combination Product (Y/N): N
• Initial Reporter Country: MO
• PMA/510(K) Number: K201607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 16.1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention