MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-07-23 for VARISOURCE IX SERIES AFTERLOADER VERSION 1.2.1 manufactured by Varian Medical Systems.
[6191067]
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.
Patient Sequence No: 1, Text Type: D, B5
[13968448]
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).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1124791-2015-00002 |
| MDR Report Key | 4954266 |
| Report Source | 05,06 |
| Date Received | 2015-07-23 |
| Date of Report | 2015-06-23 |
| Date of Event | 2015-06-23 |
| Date Mfgr Received | 2015-06-23 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2015-08-03 |
| 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, MANAGER |
| Manufacturer Street | 501 LOCUST AVE., SUITE 1 |
| Manufacturer City | CHARLOTTESVILLE VA 22902 |
| Manufacturer Country | US |
| Manufacturer Postal | 22902 |
| Manufacturer Phone | 4349518635 |
| Manufacturer Street | 501 ;PCIST AVE/. SIUTE 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 |
| Product Code | JAQ |
| Date Received | 2015-07-23 |
| Model Number | VERSION 1.2.1 |
| 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 ALSO CA 94304 US 94304 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-23 |