MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-04 for VARIAN TRUEBEAM H193889 manufactured by Varian Medical Systems.
[187551507]
Customer reported that multiple breast cancer patients were treated with truebeam gating marker block and had unexpected skin reactions. Varian reviewed the images and the treatment plan data provided by the customer for 3 patients. In all 3 cases, the skin reactions do not appear life threatening and are within the spectrum of the type of skin reactions seen in radiation treatments for the breast without any bolus. Radiation dermatitis is a common side effect of radiotherapy. Whenever something is placed on the skin and is in the treatment field, there can be a "bolus" effect increasing skin dose. Typically, it is standard practice that all external devices that are in the treatment beam path should be modeled in the treatment planning system. This can assess the dose the skin is getting so that a clinical decision can be made as to whether the dose is too high to the skin. Reviewing the customer provided treatment plan indicated that the gating marker block was not incorporated into the plan dosimetry. Not including the gating box in the treatment plan dose calculation would constitute user error. Any object placed between the radiation source and the patient could potentially affect the treatment. Users must verify the dose correction factor to include potential bolus effects. The truebeam instructions for use cautions the user to verify dose correction factor including any possible bolus effect when any object is placed between the radiation source and the patient.
Patient Sequence No: 1, Text Type: N, H10
[187551508]
Customer reported that multiple breast cancer patients were treated with truebeam gating marker block and had unexpected skin reactions. Customer provided images of 3 patients that were thought to have had increased skin reactions versus what is expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916710-2020-00002 |
| MDR Report Key | 9666712 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-03-20 |
| Date Added to Maude | 2020-02-04 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. K. SEMONE |
| Manufacturer Street | 911 HANSEN WAY |
| Manufacturer City | PALO ALTO CA 943041028 |
| Manufacturer Country | US |
| Manufacturer Postal | 943041028 |
| Manufacturer Phone | 6504246833 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARIAN TRUEBEAM H193889 |
| Generic Name | LINEAR ACCELARATOR |
| Product Code | IYE |
| Date Received | 2020-02-04 |
| Model Number | H19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | 911 HANSEN WAY PALO ALTO CA 94304 US 94304 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-04 |