MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-02-28 for SMX/GENERAL 114670A01-01 manufactured by Nucletron Bv.
[18206277]
When exporting plan data to an rtp link file, oncentra simulation is designed in such a way that only export plan data which is supported by the simulator is transferred. Info on this is stated in the oncentra simulation user manual ((b)(4)). Treatment plan data which is not supported by the simulator is not exported to rtp link. This includes dose values, mus, wedges, bolus and compensators. These items are left out which require the user to verify correct input of all parameters into other systems using the approved treatment plan. The values that are being left out is a precaution measure and safety feature to avoid that the transferred data is used for treatment delivery without any further verification. The typical next step in the workflow would be to send the plan back to a treatment planning system to recalculate the dose values and needed beam limiting accessories. A customer info bulletin (cib) has been created and distributed to all oncentra simulation customers worldwide.
Patient Sequence No: 1, Text Type: N, H10
[18375314]
The customer exported a treatment plan with wedges in the beams to oncentra simulation (ocs). During the simulation, the customer decided to make some beams a little longer so he made a copy of the plan. While in this status, not in the modus verification anymore as real simulation, he simulated the pt and made some changes for some beams. After the simulation, he exported the plan from ocs 2. 4 to lantis via rtp link. At lantis, he imported the plan and saw that the mu's were 0 for all beams. The customer then entered the mu's manually, but was not aware that the wedges of the beams were not in anymore and no longer part of the treatment plan. He treated the pt with the same count of mu but as an open field without the wedge for the beams. A mistreatment took place. The pt was planned for 20 fractions of 2 gy each. He received 10 fractions in total of 60 gy. When this was detected, the radiotherapy session was cancelled and the treatment not finalized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611894-2011-00001 |
| MDR Report Key | 2011908 |
| Report Source | 05,06,07 |
| Date Received | 2011-02-28 |
| Date of Report | 2011-02-28 |
| Date of Event | 2011-01-28 |
| Date Mfgr Received | 2011-01-28 |
| Date Added to Maude | 2012-05-23 |
| 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 | DEBRA BENSEN |
| Manufacturer Street | 7021 COLUMBIA GATEWAY DR STE 200 |
| Manufacturer City | COLUMBIA MD 21046 |
| Manufacturer Country | US |
| Manufacturer Postal | 21046 |
| Manufacturer Phone | 4435452220 |
| Manufacturer G1 | NUCLETRON B.V. |
| Manufacturer Street | WAARDGELDER 1 |
| Manufacturer City | VEENENDAAL 3904 |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 3904 |
| Single Use | 0 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMX/GENERAL |
| Generic Name | ONCENTRA SIMULATION |
| Product Code | KPQ |
| Date Received | 2011-02-28 |
| Model Number | 114670A01-01 |
| ID Number | VERSION 2.4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUCLETRON BV |
| Manufacturer Address | VEENENDAAL NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-28 |