MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS VARISOURCE IX SERIES AFTERLOADER

Model Number VERSION 1.2.1

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2015

Event Type  malfunction  

Event Description

A product problem discovered during pt treatment was reported to varian medical systems regarding the varisource ix afterloader software.The user received an error during treatment and attempted to clear the error during which the control software logged the user out and required the user to log back in.The user was also required to abort and create a partial fraction to resume the treatment.After selecting the "make new fraction from undelivered portion" treatment recovery option, the resulting fraction included a channel which had already been delivered.The pt was not affected by this issue as the user decided to stop treatment and catch up this fraction at the end of the treatment course.There is a potential risk of serous injury if the scenario of treatment interrupt during an hdr treatment were to recur.

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 version 1.2.1 of the varisource ix software.Varian ref.Number: (b)(4).

• Brand Name: VARISOURCE IX SERIES AFTERLOADER
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 3100 hansen way; palo also CA 94304
• Manufacturer Contact: rachel forsberg, manager ; 501 locust ave., suite 1; charlottesville, VA 22902 ; 4349518635
• MDR Report Key: 4954266
• MDR Text Key: 6191067
• Report Number: 1124791-2015-00002
• 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: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VERSION 1.2.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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