FDA Adverse Event Malfunction Summary report: N

ARIA RADIATION ONCOLOGY

MDR report key: 2031749 · Received February 25, 2011

Report

Report Number: 2916710-2011-00016
Event Type: Malfunction
Date Received: February 25, 2011
Date of Event: January 31, 2011
Report Date: January 31, 2011
Manufacturer: VARIAN MEDICAL SYSTEMS
Product Code: IYE
PMA / PMN Number: K093527
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A MALFUNCTION OF THE DEVICE. METHOD: THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem · 1

DOSE TO BE DELIVERED EXCEEDS SESSION DOSE LIMITS IN REFERENCE POINT TAB. REFERENCE POINT TAB REVEALED DOSE TO BE RECORDED IN CHART AS (B)(4). HISTORY TAB REVEALED 5 FRACTIONS DELIVERED, WITH FRACTIONS 4 AND FRACTION 5 IN THE SAME SESSION (SESSION 5). TOTAL DOSE TO PRIMARY REFERENCE POINT (B)(4), SESSION OVERRIDES FOR SESSION 5. PER CUSTOMER, THIS SESSION REMAINED "PARTIALLY COMPLETED ACTIVE" AND HE HAD TO FINISH THIS SESSION IN RT CHART. PRESCRIPTION TAB REVEALED THE PLAN PRESCRIPTION FOR DELIVERED NUMBER OF FRACTIONS "4" AND A DELIVERED DOSE TO DATE OF (B)(4), WITH A PLANNED TOTAL DOSE OF (B)(4). SCHEDULING TAB REVEALED AN IMAGE AND PLAN REVISION AT SESSION #1, ANOTHER PLAN REVISION FOR SESSION 2. THE CUSTOMER MADE A PLAN REVISION TO AVOID UNINTENDED ADDITIONAL DOSE. THERE WAS NO REPORT OF MISADMINISTRATION OR SERIOUS INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ARIA RADIATION ONCOLOGY	TREATMENT PLANNING SYSTEM	IYE	VARIAN MEDICAL SYSTEMS	HRO09

Patients

Seq	Age	Sex	Outcome	Treatment
1