MAUDE Adverse Event Report: BRAINLAB AG EXACTRAC 5.5; PATIENT POSITIONING SYSTEM, RADIATION THERAPY

Model Number 20818C

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since treatment fields and one of three planned fractions of therapeutic radiation dose intended for a different target volume - for a different plan for a different target location for the same patient - were applied to the positioned target volume, despite according to the hospital (physician): the clinically acceptable limits defined by this hospital radiotherapy department are not exceeded for this patient due to this issue as per the current hospital's estimation.The physician decided to re-deliver the treatment fraction that was erroneously given to the first target, to the intended second target volume.There were no negative clinical effects for this patient reported by the hospital.There are no other remedial actions for this patient reported by this hospital to be intended for this patient, except careful monitoring in the post-treatment period.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the radiation treatment fraction applied to the other target volume than it was planned for, is an isolated case human error by selecting a different treatment plan for the same patient for positioning with exactrac than at the linear accelerator.There is no indication of an error or malfunction of the brainlab device (exactrac).The brainlab device works correctly as intended.Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.The customer has communicated that users at this hospital are already aware of the corresponding necessary user verification also with the functions available in the brainlab device (exactrac), to ensure matching treatment plans in both exactrac and the linear accelerator.The hospital has corresponding internal procedures already in place, only in this isolated specific case, these hospital procedures in place were apparently not correctly followed.(correspondingly, there are no re-iterations regarding the use of the device are applicable for this customer for this isolated case human error).

Event Description

Two separate treatment plans for stereotactic radiotherapy for two meningioma tumors for the same patient were imported into the brainlab exactrac 5.5 system, used for the positioning of the patient at the linear accelerator, and imported into the linear accelerator.Prescribed/intended were 3 treatment fractions for each tumor, with a radiation dose of 7.5 gy per fraction.The first tumor had a size of ca.1.3 ccm, the second a size of ca.2.6 ccm.When setting up the patient for the second treatment fraction of the second tumor, the physicist detected before irradiation of this fraction that the patient was positioned to the first tumor as per the display by exactrac.The plan currently open in the linear accelerator was the one for the second tumor.After detecting this mismatch of the plans selected, the hospital's review of this patient treatment so far revealed that the treatment fields and dose intended for the first fraction of the second tumor had been erroneously delivered to the first tumor.Since the second tumor was larger than the first, the multi-leaf-collimator treatment field aperture had been wider than the treatment target volume of the mistakenly irradiated first tumor at that former fraction.According to the hospital (physician): the clinically acceptable limits for normal tissue defined by this hospital radiotherapy department are not exceeded for this patient due to this issue as per the current hospital's estimation.The physician decided to re-deliver the treatment fraction that was erroneously given to the first target, to the intended second target volume.There were no negative clinical effects for this patient reported by the hospital.There are no other remedial actions for this patient reported by this hospital to be intended for this patient, except careful monitoring in the post-treatment period.

• Brand Name: EXACTRAC 5.5
• Type of Device: PATIENT POSITIONING SYSTEM, RADIATION THERAPY
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: markus hofmann ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 7797932
• MDR Text Key: 117864231
• Report Number: 8043933-2018-00024
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K072506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20818C
• Device Catalogue Number: 49918A
• Device Lot Number: SW V. 5.5.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other