MAUDE Adverse Event Report: BRAINLAB AG IPLAN RT DOSE (SW VERSION 4.1.3); RADIATION THERAPY TREATMENT PLANNING

Model Number 21213G

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems Radiation Underdose (2166); No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2014

Event Type  No Answer Provided  

Event Description

A frameless srs patient treatment was planned with brainlab iplan rt dose 4.1.3.The plan was intended for treatment of intra-cranial metastatic lesions located in 3 different regions/isocenters.The customer prescribed 100% dose to 99% of the volume to all three ptvs (defined as "hard constraints").During the final dose adjustment, a mlc leaf in one of the treatment groups was manually adjusted to achieve better dose coverage.The customer locked this treatment group after the adjustment and refreshed the mu.After that refresh the prescription of the according ptv was still fulfilled, but the prescription for the other two ptvs was not fulfilled, but the prescription for the other two ptvs was not fulfilled anymore.Instead of normalizing to the 100% dose and 99% volume hard constraint point the software normalized to the 50% volume point.During the required verification of the treatment plan the customer did not recognized that the actually planned dose differs from the intended dose for two of three ptvs.The user approved the plan and sent it to the treatment machine.The according treatment has been applied on (b)(6) 2014.During routine dose review on (b)(6) 2014 it has been detected by the hospital that approximately 20% less dose than intended was delivered to two of the three treatment groups.According to the hospital this does was determined to be still within clinical acceptable range and there is no corrective action required for this specific patient.

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 less dose then intended has been applied.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 completed of investigation.

Manufacturer Narrative

Brainlab investigation has shown that the automatic monitor units (mu) calculation (normalization) potentially might be incorrect in the brainlab iplan rt dose versions 4.0 and 4.1 if all the following conditions are met: several ptvs are planned in the treatment plan, and at least one treatment group or treatment element is locked to prevent further modification, and for any ptv with a locked treatment group or with at least one locked treatment element assigned the dose at the 50 percent volume constraint point deviates more than 5 percent from the actual dose at 50 percent volume.For further details please refer to the attached 21 cfr 806 relevant information.Brainlab intends the following corrective actions (concluded on 06/09/2015): existing potentially affected iplan rt dose version 4.0 or 4.1 customers receive a product notification information; brainlab will provide a software solution to prevent the described scenario from occurring.Brainlab will actively contact affected customers tentatively starting january 2016 to schedule the update.

• Brand Name: IPLAN RT DOSE (SW VERSION 4.1.3)
• Type of Device: RADIATION THERAPY TREATMENT PLANNING
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen 85622 ; GM 85622
• Manufacturer Contact: julia mehltretter ; kapellenstrasse 12; feldkirchen 85622 ; GM 85622 ; 99915680
• MDR Report Key: 3842639
• MDR Text Key: 18794915
• Report Number: 8043933-2014-00016
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21213G
• Device Catalogue Number: 70263
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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