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

Model Number 48355

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

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, although: - there is no indication of an error or malfunction of the brainlab device - the corresponding measures to minimize this anticipated risk to be as low as reasonably practicable are already in place - a single fraction out of 25 was delivered to a not-intended location, no negative clinical effects to the patient have thus far been reported.Per the customer, the treatment of the patient consists of 25 fractions (i.E.Not radiosurgery), no medical intervention was necessary or is planned and the treatment is continued with exactrac.According to the results of brainlab investigation, the root cause for the not-intended patient position is user error.Investigation of the provided patient data, log files and software system (ini) files of the exactrac system revealed the following: the result of the poor automatic image fusion during the x-ray verification step was not noticed and not corrected by the user.Since patient positioning is based on the result of the image fusion, this lead to a not-intended patient positioning during the subsequent treatment.·x-ray correction: correction shifts resulted as usual.The log file shows that the user did not inspect the result of the image fusion, however the fusion algorithm worked well and the fusion and correction shifts can be considered good.·movement of robotics and couch: the calculated shifts were sent to the robotics and couch.The robotics couch did not reach the target position.This issue of robotics was shown in a message box and acknowledged by the user.·x-ray verification: since the target position was not reached, the user has the option to restart positioning.However, the user proceeded with the x-ray verification step.The fusion detected a deviation, which was subsequently actively applied by the user.The user appears to not have inspected the fusion of the x-ray verification step carefully since the significant visible mismatch was apparently not noticed and the calculated shift was used for patient positioning.·movement of robotics and couch and authorization for treatment: the faulty correction shifts were used for patient positioning and subsequent treatment, which was delivered as confirmed by the customer.There is no indication of a malfunction or quality or performance issue with the brainlab device.According brainlab measures to minimize this anticipated risk to be as low as reasonably practicable are already in place.Brainlab intends to: - inform this hospital about the investigation results, - offer an additional training to users at this hospital.

Event Description

A patient was treated in a not-intended position during an exactrac workflow.·the customer used exactrac 6.1.1 for patient positioning for a cranial rt treatment.·as part of the x-ray correction step in the workflow, the software calculated correction shifts which were sent to the robotics couch as usual.The movement of the robotics couch was interrupted, resulting in the target position not being reached.·the user subsequently entered the x-ray verification step and performed an image fusion of poor accuracy (the x-ray and drr images did not match spatially).The resultant faulty verification shifts were applied by robotics and the couch.·this resulted in a non-optimal positioning of the patient for the cranial rt treatment.A treatment fraction was delivered to the patient.A single fraction out of 25 was delivered to a not-intended location, no negative clinical effects to the patient have thus far been reported.Per the customer, the treatment of the patient consists of 25 fractions (i.E.Not radiosurgery), no medical intervention was necessary or is planned and the treatment is continued with exactrac.

• Brand Name: EXACTRAC 6.2
• Type of Device: PATIENT POSITIONING SYSTEM, RADIATION THERAPY
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; munich, 81802 9; GM 818029
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; munich, 81829 ; GM 81829
• Manufacturer Contact: paul neil ; olof-palme-strasse 9; munich, 80829 ; GM 80829
• MDR Report Key: 6844999
• MDR Text Key: 86009411
• Report Number: 8043933-2017-00025
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 04056481000264
• UDI-Public: 04056481000264
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K120789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physicist
• Type of Report: Initial
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physicist
• Device Model Number: 48355
• Device Catalogue Number: 20834E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2016
• 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