MAUDE Adverse Event Report: ELEKTA NUCLETON

Model Number MICROSELECTRON V3

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/10/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015 at approx 14:57:56 an hdr procedure was aborted due to a software/equipment malfunction.The events leading up to this are as follows: daily qa performed at 13:36 without incident.Tcs software left open but workstation locked as is consistent with clinic workflow.Workstation unlocked and pt plan loaded at approx 14:45.Plan summary compared with printed treatment report from planning system according to pre-treatment checklist.All parameters match printout.Remove after-loader from closet and call physician to connect transfer tube to applicator.Leave room and shut door.Position camera so after-loader and pt are visible.Time out performed with physician at console re-verifying all treatment parameters agree with treatment plan.All parameters match printout.Physician authorizes treatment at 14:56:26.Physicist notices the tcs software indicates the door is still open.Physicist walks over to door and presses paddle again and sees the door is closing.Physician hears the alarm which indicates software is ready for treatment to be started.Physician presses start button.Physician notices the alarm indicating "ready for treatment" is still sounding.This is not normal as the alarm is supposed to stop once treatment is initiated.Physicist has not seen the check cable or source leave the safe.Physicist looks at console to see what is happening, after a slight delay the alarm stops sounding as if treatment has been started.Physician looks at video monitor and sees check cable leave safe and come back, followed by the source leaving the safe.The physicist also verifies that the area monitor is flashing, indicating that radiation is detected in the room.Physicist looks at console display and notices that the remaining treatment time display is counting up instead of counting down and the system status indicates "treatment terminated" despite the fact that the radiation time is counting up as well as the dwell display indicates the source is in the 9th dwell position.Another physicist happened to be standing nearby and said to hit the emergency stop button if there was any concern that something wasn't right.The emergency stop button was pressed at 14:57:56.Both physicists see the source retract and confirm that the area monitor stopped flashing.The physician and physicist enter the room with a survey meter to confirm there is no radiation present.Upon entering the room, the physicist also confirms that the in room area monitor is not flashing.Also the survey meter is reading background (approx 2-5ur/hr).The physician informs the pt that something is not working properly with the computer which is why treatment was stopped.He assures her everything is fine but that we need to figure out what is wrong before continuing treatment.The pt is removed from room.At the console the physicians see that 41.8 seconds of radiation has been delivered in the 9th dwell position according to the radiation time display.The treatment report is opened for viewing which does not show that any radiation has been delivered.The emergency print button on the console control is pressed.The report indicated that the source was at position 1460mm (which corresponds to the 9th dwell position) for 41.8 seconds.The mfr (nucletron/elekta) was called and informed of the situation shortly after.The person we initially spoke with was not the appropriate person to help with the situation, but said they would have someone call us back quickly.The rso for the hospital is notified.While waiting for a returned call from elekta, we contacted our regular service engineer and asked him to come on-site.Our regular service engineer came onsite and a support person from the mfr was on the phone to help diagnose what the malfunction was.They found a log file showing there was a communication error.The software has no record of the partial treatment which took place.After several repeated attempts we are unable to reproduce the event or otherwise make the system behave in any way other than expected normal function.Diagnosis or reason for use: uterus cancer.

• Brand Name: NUCLETON
• Type of Device: NUCLETON
• Manufacturer (Section D): ELEKTA
• MDR Report Key: 5088395
• MDR Text Key: 26567946
• Report Number: MW5056254
• Device Sequence Number: 1
• Product Code: JAQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MICROSELECTRON V3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR