MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTISTE MV; ACCELERATOR, LINEAR, MEDICAL

Model Number 8139789

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

The reporting facility phone number was is: (b)(6).Siemens has initiated a technical investigation of the reported event.Although the preliminary root cause of this event was user error, the investigation is ongoing.A supplemental report will be submitted when the investigation has been completed.

Event Description

It was reported to siemens by the customer that a patient had a treatment plan at two sites.Both plans (for each site) had been loaded from ois (aria) into the rt therapist application (rtt).The customer acquired for the second displayed (bottom) plan on the rtt display the setup beams, performed a workflow "edit mode" afterwards to change the beam order.Due to the workflow "edit mode" the plan was then displayed at the top position in rtt.The customer did not realize this and then selected the beams of the second displayed site for treatment which resulted in treatment to the wrong location.It is a common behavior of rtt to put the last changed plan on the top of the list.The event led to patient mistreatment.In the present case, the customer mixed up two plans in rtt and transferred wrong field parameters to the system which led to a dose (5 gy) to the wrong location.The customer reported that the mistreatment had no further clinical relevance for the patient because both plans had no significantly different volumes/shapes.If this event were to reoccur, a dose to the wrong location could lead to a severe patient injury.Although the customer admits to user error, the investigation is presently ongoing.This report is being submitted with an abundance of caution.The reported event occurred in (b)(6).

Manufacturer Narrative

Siemens completed the investigation of the reported event.The workflow identified from the system savelog matches the description provided by the customer.The table-top position was adjusted based on acquired images from one plan, but the treatment segments from another plan were delivered to the position from the other plan.Please note that this is a known behavior of the rtt.The modified plan will be moved to the top position of the list of plans in the delivery plan browser component.The user did not realize this and then selected the beams of the second displayed site for treatment.As previously reported, the root cause of the event was user error.The rtt worked as specified.

• Brand Name: ARTISTE MV
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• MDR Report Key: 10613191
• MDR Text Key: 241073772
• Report Number: 3002466018-2020-47590
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K142434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8139789
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1