FDA Adverse Event Other Summary report: N

ARIA 8.0

MDR report key: 1015952 · Received March 14, 2008

Report

Report Number
MW5005948
Event Type
Other
Date Received
March 14, 2008
Date of Event
January 18, 2008
Report Date
March 14, 2008
Manufacturer
VARIAN MEDICAL SYSTEMS
Product Code
MUJ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

OUR BILLING STAFF DISCOVERED THAT ONE PT WAS CHARGED 29 TIMES ALTHOUGH SHE/HE WAS ONLY PRESCRIBED TO RECEIVE 28 TREATMENT FRACTIONS OF RADIATION THERAPY BY THE TREATING PHYSICIAN. THE MEDICAL PHYSICISTS REVIEWED THE RECORDS WITHIN THE VARIAN ARIA RECORD & VERIFY SYSTEM AND FOUND THAT ON A MONTH EARLIER, THIS PT WAS CHARGED FOR A TREATMENT, BUT THAT NO RECORD TO THE TREATMENT HAVING OCCURRED IS PRESENT IN THE ARIA DATABASE. THE THERAPISTS ON DUTY ASCERTAINED THAT THEY DID TREAT THIS PT ON THE SAME DAY. HOWEVER, THEY DO NOT RECALL THAT AN ERROR MESSAGE APPEARED ON THE CONSOLE WHEN THEY TREATED THIS PT. THEY THEN HAD TO MANUALLY COMPLETE THE TREATMENT STATUS OF THIS PT AND MANUALLY ENTER THE CHARGE. THIS MANUAL TREATMENT IS CONFIRMED BY ARIA HISTORY RECORD. IT SHOULD BE NOTED THAT UNDER NORMAL CIRCUMSTANCES ARIA WILL AUTOMATICALLY ENTER THE CHARGE AT THE COMPLETION OF EACH FRACTION. ACCORDING TO VARIAN, IF A PT IS TREATED, BUT NOT RECORDED DUE TO AN ERROR, USERS CAN GO TO A BACKUP FOLDER. THE FACT THAT AN XML FILE WITH BEAM RECORDS IS PRESENT FOR THE PT ON THE DATE IN QUESTION, LEADS US TO BELIEVE THAT THE PT WAS ACTUALLY TREATED AND THAT ARIA FAILED TO RECORD THE TREATMENT AS HAVING OCCURRED. WE HAVE CONTACTED VARIAN MEDICAL SYSTEMS TO CONDUCT AN INVESTIGATION ON THIS CASE, BUT AT THIS TIME VARIAN CAN'T GIVE US A DEFINITE ANSWER AS TO WHETHER THIS PT WAS TREATED OR NOT ON THE DAY IN QUESTION. THIS PROBLEM WITH THE VARIAN SOFTWARE IS UNACCEPTABLE AND POSES A RISK TO PT CARE SINCE THE ACTUAL DOSE DELIVERED TO THE PT CANNOT BE VERIFIED. IN ADDITION, A RECORD AND VERIFY SYSTEM SHOULD NOT ALLOW AN INTERNAL ERROR TO CAUSE A FAILURE OF THE ARIA SYSTEM TO RECORD THAT A PT'S TREATMENT HAS OCCURRED IF IT HAS INDEED OCCURRED. NOTE: THE XML FILES DESCRIBED ABOVE ARE AVAILABLE FOR REVIEW IF REQUESTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ARIA 8.0 ARIA 8.0 MUJ VARIAN MEDICAL SYSTEMS * *

Patients

Seq Age Sex Outcome Treatment
1 Other