MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-04-24 for SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE GM11010800 manufactured by Varian Medical Systems, Inc.
[15317992]
Varian has discovered that there is a discrepancy in the absolute dose rate given with the leipzig-style surface applicator's instruction for use (ifu): dose characterization gm11010080 (b)(6) 2012. This issue was discovered by a customer during commissioning of the leipzig-style surface applicators using thermo luminescent dosimeters (tld). The customer found 24% discrepancy in their tld-measured dose as compared to the varian ifu. The most significant discrepancy is that the actual dose rate of the applicator is approximately 14% higher than the rate published within the ifu. Use of the dose rate within the ifu without independent confirmation of the dose could result in an adminstration of the dose greater than intended. The patient's treatment was prescribed for 400cgy per fraction x 8 fractions, to a depth of 3mm. The dose rate used to plan the treatment dwell time was the dose rate given in the ifu of 21. 5 cgy/min/ci (at 5mm). This would result in an overdose of 14% (456cgy per fraction). The site is anticipating making dosimetric adjustments to the final fractions. Per varian's medical professional assessment, the pt has most likely been unharmed by the overdose and would not experience a serious injury as the overdose from the 3 fractions treated results in a low risk for skin/tissue necrosis and could be further mitigated by reducing the daily fraction dose.
Patient Sequence No: 1, Text Type: D, B5
[15667793]
The issue was investigated by varian. A review of the following was carried out: the applicator ifu, data given to varian from (b)(4) as part of the (b)(4) ((b)(4) was contracted to perform characterizations of the applicators to provide data for the ifu), (b)(4) ref guide, the tld data from the clinical site, as well as a report generated by (b)(4) in 2013. The discrepancy between the dose rate published in the applicator's ifu and the dose rate from corrected (b)(4), and physical measurement was verified. The root cause was validation and verification error; a failure for (b)(4) and varian to come together and review all deliverables together at the end of the characterization project. The ifu will be updated with corrected dose rates. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612638-2015-00001 |
| MDR Report Key | 4731343 |
| Report Source | 05,06 |
| Date Received | 2015-04-24 |
| Date of Report | 2015-03-26 |
| Date of Event | 2015-03-26 |
| Date Mfgr Received | 2015-03-26 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-06-09 |
| 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 G1 | VARIAN MEDICAL SYSTEMS HAAN GMBH |
| Manufacturer Street | BERGISCHE STRASSE 16 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE |
| Generic Name | SURFACE APPLICATOR |
| Product Code | JAQ |
| Date Received | 2015-04-24 |
| Model Number | GM11010800 |
| 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, INC |
| Manufacturer Address | 3100 HANSEN WAY PALO ALTO CA 94304 US 94304 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-24 |