MAUDE Adverse Event Report: BRAINLAB AG EXACTRAC (VERSION 6.2); PATIENT POSITIONING SYSTEM, RADIATION THERAPY

Model Number 48362

Device Problems Inadequate Instructions for Healthcare Professional (1319); Insufficient Information (3190)

Patient Problems Radiation Overdose (1510); No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

Although according to the hospital there are no negative clinical effects for this patient due to this issue, a risk to the patient's health could not be excluded for these specific circumstances, since the patient has been irradiated in a different position than intended, with the brainlab device involved.A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report to the fda upon completion of investigation.

Event Description

A patient was intended to be positioned for a prostate rt treatment on (b)(6) 2017 with brainlab exactrac patient positioning system (version 6.2) and varian truebeam radiotherapy system (version 2.5), using the auxiliary device interface (adi).Adi is utilized to send couch move requests from exactrac to the treatment application and to authorize beam requests of the treatment application by exactrac.As long as no patient is loaded within exactrac, it always authorizes every request from the truebeam side.When a patient is loaded by exactrac, exactrac verifies the position of the patient and only authorizes beam requests if the patient is correctly positioned (i.E.Ok icon visible on exactrac screen).For this specific treatment the patient has been opened on the varian truebeam and a message box for patient opening was displayed in exactrac.A beam was selected on truebeam and afterwards the message box in exactrac was acknowledged by clicking "open", which opened automatically the patient in the exactrac software.After prepositioning of the patient the correction shifts for exact patient positioning have been calculated by exactrac with the x-ray correction step.The calculated pitch and roll shifts were applied by the brainlab robotics.The translation shifts could not be applied for the couch and exactrac showed a corresponding error message.Apparently, despite the translations have not been applied and exactrac did not show the "ok" icon, the truebeam was authorized to treat and the treatment was started by the hospital's therapist.After a few seconds of treatment the hospital's therapist realized that the exactrac software does not show "ok" for correct patient positioning and he stopped the treatment.The patient has been repositioned and correct positioning was verified.The treatment could be completed as intended.According to the hospital there are no negative clinical effects for this patient due to this issue, despite the patient has been irradiated in a different position than intended.The customer additionally observed this behavior (truebeam authorized to treat despite translations are not applied) during treatments for other patients on (b)(6) 2017.For these patients no unintended irradiation occurred, since the problem has been detected before irradiation.The treatments could be performed as intended.

Manufacturer Narrative

According to the results of technical investigation and the information provided by the hospital, it can be concluded that the root cause for the incorrect treatment of the patient on (b)(6) 2017 is a combination of: use error, due to not following the required workflow order, not verifying the correct patient position and not observing the exactrac warning message before applying the treatment beam, and insufficient descriptions and warnings in the instructions for use (user guide) regarding beam authorization by exactrac via adi for further details please refer to the attached field safety notice / product notification letter capa-(b)(4).For detailed results of investigation.Brainlab conclusion: a risk to patient health cannot be excluded if this scenario would reoccur, since, if a deviation of the patient position from the planned treatment position remains undetected by the user and the actual treatment beam that has been previously authorized by exactrac via adi is initialized by the user, underdose of the planned target volume and/or overdose of healthy tissue could occur if the deviation exceeds clinically acceptable tolerances for the indication being treated.Brainlab intends the following corrective actions: 1.Existing potentially affected customers receive a product notification information.2.These customers receive the an update to the instructions for use bl-il-60960- 84_rev1.0 regarding beam authorization by exactrac via adi.The 21 cfr 806 relevant information has been submitted to fda recall coordinators.

• Brand Name: EXACTRAC (VERSION 6.2)
• Type of Device: PATIENT POSITIONING SYSTEM, RADIATION THERAPY
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; munich, 81829 ; GM 81829
• MDR Report Key: 7141576
• MDR Text Key: 95933598
• Report Number: 8043933-2017-00033
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 04056481000264
• UDI-Public: 04056481000264
• Combination Product (y/n): N
• PMA/PMN Number: K120789
• 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: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48362
• Device Catalogue Number: 20881
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other