MAUDE Adverse Event Report: IBA (ION BEAM APPLICATIONS) PROTEUSPLUS; PROTON THERAPY SYSTEM

Model Number PROTEUS 235

Device Problem Malposition of Device (2616)

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

Event Date 04/02/2020

Event Type  malfunction  

Event Description

Event description : on (b)(6) 2020, during a craniospinal treatment with multiple isocenters, the user observed an unwanted shift in the patient positioning system (pps) position.As the discrepancy was higher than tolerances defined in the oncology information system, a message was displayed to the user.Therefore, the issue was noticed before starting the proton field and no mistreatment occurred.The user corrected the patient positioning system position and resumed treatment.Preliminary analysis: depending on the treatment room configuration, a treat-rot position can be available in the positioning management system.Treat-rot position is defined as follows: x, y, z equal to x, y, z of the pps current position.And rot, pitch and roll equal to the rot, pitch and roll of the pps prescribed position.Switching from one treatment beam to the next treatment beam with a different isocenter using treat-rot position will not apply the necessary motion along x, y and z axes.If the user does not notice the discrepancy in pps position, the patient may be treated at the incorrect position.

Event Description

Event description (from initial report): on (b)(6) 2020, during a craniospinal treatment with multiple isocenters, the user observed an unwanted shift in the patient positioning system (pps) position.As the discrepancy was higher than tolerances defined in the oncology information system, a message was displayed to the user.Therefore, the issue was noticed before starting the proton field and no mistreatment occurred.The user corrected the patient positioning system position and resumed treatment.Preliminary analysis (from initial report): depending on the treatment room configuration, a treat-rot position can be available in the positioning management system.Treat-rot position is defined as follows: - x, y, z equal to x, y, z of the pps current position.- and rot, pitch and roll equal to the rot, pitch and roll of the pps prescribed position.Switching from one treatment beam to the next treatment beam with a different isocenter using treat-rot position will not apply the necessary motion along x, y and z axes.If the user does not notice the discrepancy in pps position, the patient may be treated at the incorrect position.Evaluation summary (supplemental report): event analysis identified an issue when the proton therapy system configuration includes the option "treatment position without translation axes", known as "treat rot position".Treat rot position is defined as follows: - x, y and z positions equal to positions of the patient positioning system (pps) in x, y, z when entering the prepare activity, - rot, pitch and roll equal to the prescribed position of pps in rot, pitch and roll, - gantry and snout positions are equal to the prescribed gantry and snout positions.Depending on the sequence of actions performed by the therapist, the use of the treat rot position when treating a second or subsequent isocenter in a multiple isocenter plan may introduce an unwanted shift in pps translations and a treatment field may be delivered at the incorrect isocenter.Iba initiated a field safety corrective action in the european union (eu) as the issue affects two proton therapy sites located in eu.No proton therapy systems in the us are affected by this issue.

• Brand Name: PROTEUSPLUS
• Type of Device: PROTON THERAPY SYSTEM
• Manufacturer (Section D): IBA (ION BEAM APPLICATIONS); chemin du cyclotron 3; louvain-la-neuve, 1348 ; BE 1348
• MDR Report Key: 10013122
• MDR Text Key: 191198616
• Report Number: 3000256071-2020-00002
• Device Sequence Number: 1
• Product Code: LHN
• Combination Product (y/n): N
• PMA/PMN Number: K101508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROTEUS 235
• Device Catalogue Number: PROTEUS 235
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other