MAUDE Adverse Event Report: BRAINLAB AG M3 (MICRO-MULTILEAF COLLIMATOR); MICRO-MULTI-LEAF COLLIMATOR

Model Number 41600

Device Problem Compatibility Problem (2960)

Patient Problems Radiation Overdose (1510); Radiation Underdose (2166); Radiation Exposure, Unintended (3164)

Event Date 09/14/2010

Event Type  malfunction  

Event Description

The hospital info brainlab that during quality assurance tests with dynamic arcs they have detected that the measured dose did not correspond to the planned dose in two of eight arcs.Further it has been detected with a lightfield test that the leave positions of the m3 multileaf collimator (mlc) appeared to be incorrect.During investigation of this issue, in cooperation with varian medical systems who is the responsible medical device mfr for the involved linear accelerator, it has been detected that a standard mlc controller version 5.0 was installed at this site, which is not compatible to the installed millennium mlc workstation version 6.8.As a consequence the mlc shapes associated with each arc of gantry position will execute incorrectly when the conformal arc begins or ends in the range of 180 to 360 degree portion because the mlc controller will execute shapes based on an incorrect gantry scale convention for shapes based on an incorrect gantry scale convention for this portion of the conformal arc field.(refer also to varian's urgent medical device correction letter cp-2004-147).Incorrectly executed mlc shapes may result in over - or underdosage of the target region and/or dose application to unintended regions.After the root cause of the observed dose deviation had been determined, the hospital performed research regarding potentially affected pts and informed brainlab on (b)(6) 2013 that during the treatments of 69 pts the above described error may have occurred.In the meantime the hospital has corrected the amount of potentially affected pts to 71.A comprehensive investigation regarding the clinical effects for these pts is currently conducted by the hospital, in cooperation with varian medical systems and brainlab.On (b)(6) 2010 is the date of the first pt treatment that is suspected to be affected by this error.

Manufacturer Narrative

Serious injury of one or more pt(s) with the brainlab device involved cannot be excluded at this point of time, since over- or underdosage of the target region and/or dose application to unintended regions may have occurred.According to the hospital 71 pts are potentially affected by this issue.A comprehensive investigation regarding the clinical effects for these pts is currently conducted at the hospital, in cooperation with varian and brainlab.Until now treatments of 14 pts have been analyzed and no clinically significant difference between planned and applied treatment was determined.H6: the incompatibility of standard mlc controller version 5.0 with millennium mlc workstation version 6.3 and 6.4 has already been detected by varian medical systems in 2004 (mdr # 2914292-2004-00011).An according urgent medical device correction letter had been issued by varian in (b)(6) 2004 (cp-2004-147) and further corrective and preventive actions had been taken to ensure that the affected controller version is removed from all customer sites.For m3 micro multileaf collimators installed on varian linear accelerators, varian performs the installation including installation of standard mlc controller.The controller is nto installed by brainlab.At this specific hospital most likely the erroneous device combination has been unintentionally installed when the not was moved from one linear accelerator to another by varian in (b)(6) 2010.A comprehensive investigation regarding details why this specific erroneous device combination was in use at this customer site is currently ongoing.Brainlab plans to issue a follow-up report to the fda upon completion of investigation.The mlc controller at this specific customer site was updated from version 5.0 to the compatible version 5.1 by varian medical systems, immediately after detection of the root cause of this issue.

• Brand Name: M3 (MICRO-MULTILEAF COLLIMATOR)
• Type of Device: MICRO-MULTI-LEAF COLLIMATOR
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen 8562 2; GM 85622
• Manufacturer Contact: julia mehltretter ; kapellenstrasse 12; feldkirchen 85622 ; GM 85622 ; 99915680
• MDR Report Key: 3710320
• MDR Text Key: 4247915
• Report Number: 8043933-2014-00003
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 41600
• Device Catalogue Number: 41600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2013
• Initial Date FDA Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2002
• 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