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

Model Number 48343

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Radiation Overdose (1510); Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2020

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 slightly deviated 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 fractionated 4 arc stereotactic rt treatment for a vestibular schwannoma with brainlab exactrac patient positioning system (version (b)(4)) and varian truebeam radiotherapy system (version (b)(4)) 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.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 plan was selected from the varian truebeam queue and opened, the associated plan was available in exactrac and this was also opened.After prepositioning of the patient, the correction shifts for exact patient positioning have been calculated by exactrac with the x-ray correction step.A translation shift was required, but the calculated pitch and roll shifts were within tolerance for this site and did not need correction.The brainlab robotics (pitch and roll) movements were canceled, the translation was applied for the couch, and the shift was verified by the acquisition of another orthogonal x-ray image pair (x-ray verification step).All parameters were within tolerance and no additional corrections were necessary, and the user finished all tasks in the fusion workspace in the exactrac software.A message to apply robotic movements (pitch and roll shifts) was displayed on exactrac, but despite the robotics were within tolerance, the message was not canceled by the user, and the robotic shifts were sent to varian truebeam in error.When the hospital's staff proceeded to treatment and the user pressed the motion enable button, the gantry was moved to the starting position for arc 1, and afterwards the brainlab robotics applied the pitch and roll shifts from exactrac.The root cause for this movement is not yet confirmed and is undergoing further investigation.The user did not notice the application of the robotic couch movement and despite the exactrac was now displaying the "low accuracy" icon and did not show the "ok" icon, the truebeam was authorized to treat and the treatment was started by the user.After 37 mu from arc 1 were delivered, the user noticed the low accuracy message on exactrac and stopped the treatment.The patient was repositioned and the correct positioning was verified.The treatment was completed as intended.According to the hospital there were no negative clinical effects for this patient due to this issue, despite the patient has been irradiated in a slightly deviated position than intended (with 0.7% of the total mu to be delivered).

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since a patient was irradiated in a position other than intended, despite according to the hospital: the irradiation treatment was completed as planned and scheduled for this patient: the remainder of the last fraction was delivered as planned after isocenter reposition.There was no detrimental/negative effect to the patient, and the patient has not reported any adverse symptoms due to the mu that was delivered in the incorrect position.There was no significant delay of the patient treatment (or fraction) due to this issue.There were no remedial actions done, planned or necessary for this patient/treatment or effects due to this issue (e.G.To avoid or revert serious deterioration of health).H6: according to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the main root cause for the irradiation of the patient in the wrong treatment position is: the user did not verify the patient position in exactrac before turning on the mv beam.More specifically, the user did not notice that exactrac was not showing the ok sign for positioning accuracy when the treatment was initiated.Corresponding brainlab measures to minimize this risk to an acceptable level are already in place.H7: brainlab intends to reiterate the relevant topics regarding the use of the device to this customer.

Event Description

A patient was intended to be positioned for a fractionated 4 arc stereotactic rt treatment for a vestibular schwannoma with brainlab exactrac patient positioning system (version 6.2.0) and varian truebeam radiotherapy system (version 2.7mr2.1) 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.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).Exactrac calculates translational and rotational shifts; the rotational shifts are applied by the brainlab robotics.For this specific treatment, the patient plan was opened on the varian truebeam and brainlab exactrac software.After prepositioning of the patient, the correction shifts (translation and rotation) for exact patient positioning have been calculated by exactrac with the x-ray correction step.The calculated rotational shifts (pitch and roll) were within the specified tolerance for this site.Thus the user cancelled the requested rotational shifts (which deviates from the intended workflow) and the translation shift only was applied for the couch.The cancellation of the robotics movements generated a pending rotational movement stored in the exactrac software.The translation shift was verified by the acquisition of another orthogonal x-ray image pair (x-ray verification step).All parameters were within tolerance and the exactrac correctly displayed the "ok" icon.However, since the user had previously cancelled the requested rotational shifts, exactrac again displayed a message to apply the rotational shifts (robotic movements) by pressing the "motion enable" button, but despite the shifts were still within tolerance, the message was not canceled by the user this time (an inconsistent workflow, which deviates from the intended and recommended workflow by brainlab).The user pressed the "motion enable" button, the gantry was moved to the starting position for arc 1, the beam was authorized, and brainlab robotics applied the rotational movements from exactrac.Due to the rotational movements applied, the treatment location was no longer at isocenter since a compensating translational movement could no longer be made and the exactrac correctly displayed the "low accuracy" icon.The user did not notice the application of the robotic couch movement and despite the exactrac displaying "low accuracy", the user neglected to observe this indicator and began treatment, turning on the mv beam.After 37 mu from arc 1 were delivered, the user noticed the low accuracy message on exactrac and stopped the treatment.The patient was repositioned and the correct positioning was verified.The treatment was completed as intended.According to the hospital: the problem occurred on the last (6th) fraction of a fractionated 4 arc stereotactic treatment for a vestibular schwannoma.37 mu (0.7% of the total mu to be delivered) were given with the isocenter at the incorrect position.The irradiation treatment was completed as planned and scheduled for this patient: the remainder of the last fraction was delivered as planned after isocenter reposition.There was no detrimental/negative effect to the patient, and the patient has not reported any adverse symptoms due to the mu that was delivered in the incorrect position.There was no significant delay of the patient treatment (or fraction) due to this issue.There were no remedial actions done, planned or necessary for this patient/treatment or effects due to this issue (e.G.To avoid or revert serious deterioration of health).

• Brand Name: EXACTRAC (VERSION 6.2)
• Type of Device: PATIENT POSITIONING SYSTEM, RADIATION THERAPY
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 10465355
• MDR Text Key: 206580324
• Report Number: 8043933-2020-00043
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 48343
• Device Catalogue Number: 20882-01
• Device Lot Number: S.W. V. 6.2.0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other