FDA Adverse Event Summary report: N

NUCLETRON

MDR report key: 3121859 · Received May 15, 2013

Report

Report Number
MW5030217
Date Received
May 15, 2013
Date of Event
April 23, 2013
Report Date
May 15, 2013
Manufacturer
ELEKTA/NUCLETRON
Product Code
JAQ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

A PATIENT OF (B)(6), CAME TO THE CLINIC TO RECEIVE FRACTION 3 OF 5 SCHEDULED FRACTIONS OF HDR THERAPY. IN PREPARATION FOR THE TREATMENT, A WARM-UP AND DAILY QA PROCEDURE WAS PERFORMED ON THE HDR SYSTEM BY PHYSICS. THE PATIENT'S APPLICATOR WAS POSITIONED FOR TREATMENT BY THE PHYSICIAN AND THE POSITION WAS VERIFIED BY TAKING AP AND LATERAL IMAGES AND COMPARING THEM WITH THE ORIGINAL SIMULATION IMAGES USED FOR TREATMENT PLANNING. THE HDR UNIT WAS CONNECTED TO THE APPLICATOR VIA THE DESIGNATED TRANSFER TUBES. THE PATIENT'S PLAN WAS OPENED AND REVIEWED AND THE PATIENT WAS TREATED. UPON COMPLETION OF TREATMENT THE PATIENT WAS SURVEYED, DISCONNECTED FROM THE HDR UNIT, THE APPLICATOR TAKEN AWAY, AND THE PATIENT WAS SENT TO CHANGE. IMMEDIATELY AFTER TAKING CARE OF THE PATIENT, THE TREATMENT REPORT WAS PRINTED AND REVIEWED FOR FRACTION WHICH HAD JUST BEEN DELIVERED. IT WAS EVIDENT AS THE REPORT WAS COMPARED TO THE PREVIOUS FRACTIONS AND THE ORIGINAL PLAN THAT THE TIME OF DELIVERY WAS LESS THAN THE PREVIOUS TIME OF DELIVERY. SINCE THERE HAD NOT BEEN A SOURCE EXCHANGE BETWEEN DELIVERIES, THERE WAS NO REASON TO EXPECT A SHORTER DELIVERY TIME. ON THE CONTRARY, A LONGER DELIVERY TIME WAS EXPECTED, IN PROPORTION TO THE DECAY OF THE SOURCE SINCE THE LAST FRACTION DELIVERED. THIS LED TO FURTHER REVIEW IN WHICH IT WAS FOUND THAT THE SOURCE STRENGTH LISTED FOR THAT DAY WAS GREATER THAN THE SOURCE STRENGTH LISTED FOR THE PREVIOUS TREATMENTS. AGAIN, IT WAS EXPECTED TO BE LESS, DUE TO DECAY OF THE SOURCE. IT WAS THEN FOUND THAT THE DATE PRINTED ON THE TREATMENT REPORT WAS DIFFERENT THAN THE ACTUAL DATE. THE DATE CHANGE CAUSED THE TREATMENT DELIVERY COMPUTER TO REGISTER A HIGHER SOURCE ACTIVITY FOR THE TREATMENT, WHICH RESULTED IN A SHORTER TREATMENT TIME. AT THAT POINT PHYSICS CALLED THE NUCLETRON ENGINEER TO FIND OUT WHAT ALLOWED A CHANGE IN DATE TO THE TREATMENT DELIVERY COMPUTER. THE ENGINEER EXPLAINED THAT WHEN HE UPGRADED THE SYSTEM, WHICH INCLUDED CHANGING THE LAPTOP BUT KEEPING THE HARD DRIVE, THE DATE MUST HAVE BEEN WRONG ((B)(6)). HE INDICATED THAT THE DIFFERENCE IN DATE BETWEEN THE TREATMENT COMPUTER AT THE CONSOLE AND THE TREATMENT DELIVERY UNIT IN THE ROOM SHOULD HAVE TRIGGERED AN ERROR CONDITION AND SHOULD NOT ALLOW TREATMENT UNTIL THE DATES WERE BROUGHT INTO ALIGNMENT. UPON UNDERSTANDING THE PROBLEM, THE DATE WAS CORRECTED ON BOTH UNITS, AND THE CORRECT SOURCE ACTIVITY WAS VERIFIED FOR THE INSTALLED SOURCE AND CURRENT DATE. THE MAKE-UP TIME NEEDED TO COMPLETE THE PATIENT'S TREATMENT FOR FRACTION 3 WAS CALCULATED BY PHYSICS AND PROGRAMMED IN THE TREATMENT DELIVERY COMPUTER AS A MAKEUP DELIVERY. THE PATIENT WAS THEN BROUGHT BACK TO THE IMAGING/TREATMENT AREA TO COMPLETE THE TREATMENT. THE PATIENT'S APPLICATOR WAS POSITIONED FOR TREATMENT BY THE PHYSICIAN AND THE POSITION WAS VERIFIED BY TAKING AP AND LATERAL IMAGES AND COMPARING THEM WITH THE ORIGINAL SIMULATION IMAGES USED FOR TREATMENT PLANNING. THE HDR UNIT WAS CONNECTED TO THE APPLICATOR VIA THE DESIGNATED TRANSFER TUBES. THE PATIENT'S MAKE-UP PLAN WAS VERIFIED FOR ACCURACY, INCLUDING DATE, SOURCE STRENGTH AND DWELL TIME FOR EACH DWELL POSITION. THE TREATMENT WAS COMPLETED AND THE PATIENT WAS SURVEYED, DISCONNECTED FROM THE HDR UNIT, THE APPLICATOR TAKEN AWAY, AND THE PATIENT WAS SENT TO CHANGE. TOTAL TIME TO DELIVER BOTH PARTS OF THIS TREATMENT WAS APPROXIMATELY 1.5 HOURS, INCLUDING DATE CORRECTION, MAKE-UP TIME CALCULATION, AND RE-POSITIONING. IT WAS VERIFIED THAT THE COMPLETE TREATMENT WAS DELIVERED TO THE PATIENT AND TO THE SITE IT WAS INTENDED TO BE DELIVERED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
214475 NUCLETRON HDR UNIT JAQ ELEKTA/NUCLETRON MICRO SELECTION 30

Patients

Seq Age Sex Outcome Treatment
1 Other