ACUITY
Received Mar 19, 2014 · Event occurred Jan 1, 2014
Report 8020711-2014-00002 · MDR key 3720556
Device
Product problems
- Use of Device Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
VARIAN IS FILING THIS MDR BASED ON POTENTIAL INJURIES POTENTIALLY INVOLVING MULTIPLE PATIENTS. ADDITIONAL FOLLOW UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).
Description of Event or Problem
VARIAN WAS ADVISED OF POTENTIAL MIS-ADMINISTRATIONS AT (B)(6). BASED ON REPORTED INFORMATION, THE SITE USES THE ACUITY SIMULATOR WITH FAD 80 MODE. THE REPORTS INDICATE THE PHYSICISTS DID NOT USE THE FIELD SIZE VALUES DISPLAYED ON THE ACUITY SIMULATOR. INSTEAD, THEY INCREASED THE TARGET AREAS ON THE LINEAR ACCELERATOR BY 20%, BELIEVING THEY WERE ADJUSTING FOR DIVERGENCE. THIS WAS UNNECESSARY AS THE ACUITY AUTOMATICALLY SIMULATES THE FAD 80 TECHNIQUE OF THE VARIAN LINEAR ACCELERATOR. AS A RESULT, MIS-ADMINISTRATION MAY HAVE OCCURRED.