MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS VARISOURCE IX SERIES AFTERLOADER; BRACHYTHERAPY SYST., REMOTE AFTERLOAD

Model Number VERSION 1.2.2.

Device Problems Computer Software Problem (1112); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/16/2015

Event Type  malfunction  

Event Description

A product problem discovered during qa testing was reported to varian medical systems regarding the varisource ix after-loader software.Following a power failure the treatment of recover of an interrupted fraction incorrectly includes all channels and dwell positions.Both the treatment recovery report and the partial fraction created do not reflect the dwell positions delivered prior to the treatment interruption.If used following power failure, the created partial fraction plan would lead to retreatment of the previously delivered dwell positions.No patient was affected by this issue; however, there is a potential risk of serious injury if the scenario of treatment interrupt during an hdr treatment were to recur.This issue is specific to varisource ix software version 1.2.2.

Manufacturer Narrative

The issue was replicated by a varian engineer in the lab.It was determined that the root cause of this issue is a coding error in version 1.2.2.Of the varisource ix software.This error is not present in versions that pre-date 1.2.2.(b)(4).

• Brand Name: VARISOURCE IX SERIES AFTERLOADER
• Type of Device: BRACHYTHERAPY SYST., REMOTE AFTERLOAD
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 3100 hansen way,; palo alto CA 94304
• Manufacturer Contact: rachel forsberg, ra/qa mgr ; 501 locust ave., ste 1; charlottesville, VA 22902 ; 4349518635
• MDR Report Key: 4704021
• MDR Text Key: 5718472
• Report Number: 1124791-2015-00001
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VERSION 1.2.2.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1