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

Model Number PROTEUS 235

Device Problem No Apparent Adverse Event (3189)

Patient Problems Radiation Overdose (1510); Radiation Underdose (2166)

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

Use error, no malfunction of the device.

Event Description

Iba has been made aware that for one beam of a particular fraction, a patient has been treated with an accessory in place whereas no accessory was prescribed.The therapist forgot to remove the accessory.The accessory was a range shifter of 7.37 cm water equivalent thickness.As a consequence, the dose deposition has been shifted of 7.37 cm in depth, leading to overdose in the proximal tissues and to underdose in the distal tissues.The attending physician assessed that it would not have an impact on the patient.There was no malfunction of iba medical device.This event is related to a use error.

• 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
• Manufacturer Contact: sylviane berger ; chemin du cyclotron 3; louvain-la-neuve, 1348 ; BE 1348 ; 10 203787
• MDR Report Key: 6900630
• MDR Text Key: 87629689
• Report Number: 3000256071-2017-00002
• Device Sequence Number: 1
• Product Code: LHN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PROTEUS 235
• Device Catalogue Number: PROTEUS 235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2010
• 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