MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-10-29 for ACUITY H77-SIM manufactured by Varian Medical Systems.
[977349]
It as reported that the customer had some problems with some treatment plans (fields) created in acuity. When an asymmetric field is created in acuity, in random cases the field descriptor is changed to symmetric field although the field image shows that the field should be asymmetric. If this is not corrected, the treatment field is changed automatically to symmetric when the plan is opened at the treatment machine. As a result, one patient was mistreated with a symmetric field when the field should have been asymmetric. Based on the reported information, a 12 cm length of the lateral portion of the spinal cord (1. 5 cm wide section) was under dosed during one fraction by 4 gy. There were 5 planned fractions, so that portion of the spine received a 20% under dosage.
Patient Sequence No: 1, Text Type: D, B5
[8213843]
Based on the reported information, a 12 cm length of the lateral portion of the spinal cord (1. 5 cm wide section) was under dosed during one fraction by 4 gy. There were 5 planned fractions, so that portion of the spine received a 20% under dosage. The issue is believed to have occurred as a result from incorrect data received from the simulation planned with the acuity (simulator). The results were not identified until after the patient treatment with the clinac machine was complete. The issue is mitigated by normal workflow patterns, where the plan would be first approved at the treatment planning system, so that re-calculation would be required if the field parameters were changed at the simulator. It is also mitigated by the normal workflow of checking the field pattern at the treatment machine, and would be further mitigated by routine quality assurance checks. As advisory letter was provided, advising the customer of an anomaly that has been identified with the acuity radonc client software where the field axis properties can change during a simulation. A new service pack is available to all customers as part of an ongoing class iii correction. A varian service representative will contact the customer to schedule the appropriate upgrade. No follow-up reports are anticipated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020711-2008-00009 |
| MDR Report Key | 1216663 |
| Report Source | 05,06 |
| Date Received | 2008-10-29 |
| Date of Report | 2008-09-29 |
| Date of Event | 2008-08-12 |
| Date Mfgr Received | 2008-09-29 |
| Device Manufacturer Date | 2003-09-01 |
| Date Added to Maude | 2008-11-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID HALL, MANAGER |
| Manufacturer Street | 911 HANSEN WAY |
| Manufacturer City | PALO ALTO CA 93404 |
| Manufacturer Country | US |
| Manufacturer Postal | 93404 |
| Manufacturer Phone | 6504833153 |
| Manufacturer G1 | VARIAN MEDICAL SYSTEMS UK LTD. |
| Manufacturer Street | GATWICK RD. |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RG |
| Manufacturer Country | UK |
| Manufacturer Postal Code | RH10 9RG |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUITY |
| Generic Name | SIMULATOR |
| Product Code | KPQ |
| Date Received | 2008-10-29 |
| Model Number | H77-SIM |
| ID Number | V 8.1.18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1266606 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-29 |