MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-04-15 for VARISOURCE IX SERIES AFTERLOADER VERSION 1.2.2. manufactured by Varian Medical Systems.
[5718472]
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.
Patient Sequence No: 1, Text Type: D, B5
[13233991]
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).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1124791-2015-00001 |
| MDR Report Key | 4704021 |
| Report Source | 05,06 |
| Date Received | 2015-04-15 |
| Date of Report | 2015-03-17 |
| Date of Event | 2015-03-16 |
| Date Mfgr Received | 2015-03-17 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2015-06-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RACHEL FORSBERG, RA/QA MGR |
| Manufacturer Street | 501 LOCUST AVE., STE 1 |
| Manufacturer City | CHARLOTTESVILLE VA 22902 |
| Manufacturer Country | US |
| Manufacturer Postal | 22902 |
| Manufacturer Phone | 4349518635 |
| Manufacturer Street | 501 LOCUST AVE., STE 1 |
| Manufacturer City | CHARLOTTESVILLE VA 22902 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 22902 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARISOURCE IX SERIES AFTERLOADER |
| Generic Name | BRACHYTHERAPY SYST., REMOTE AFTERLOAD |
| Product Code | JAQ |
| Date Received | 2015-04-15 |
| Model Number | VERSION 1.2.2. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | 3100 HANSEN WAY, PALO ALTO CA 94304 US 94304 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-15 |