MAUDE Adverse Event Report: RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION; RADIATION THERAPY TREATMENT PLANNING SYSTEM

Model Number 9A

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem Overdose (1988)

Event Type  Injury  

Event Description

Material override intended for cbct was by mistake also used on the planning image set, leading to the entire patient being modeled as water.The initial override was introduced because of dose tracking on incomplete cbct and that structure was by accident mapped onto the new planning ct as well.This lead to an incorrect dose calculation and a 10% overdose of the ribs.The device functions as designed, but usability improvements will be considered to prevent similar use errors in the future.

• Brand Name: RAYSTATION
• Type of Device: RADIATION THERAPY TREATMENT PLANNING SYSTEM
• Manufacturer (Section D): RAYSEARCH LABORATORIES AB (PUBL); sveavagen 44; stockholm, 11134 ; SW 11134
• Manufacturer (Section G): RAYSEARCH LABORATORIES AB (PUBL); sveavagen 44; stockholm, 11134 ; SW 11134
• Manufacturer Contact: martin paulsen ; p.o. box 3297; stockholm, 10365 ; SW 10365
• MDR Report Key: 10273334
• MDR Text Key: 198847306
• Report Number: 3007774465-2020-00003
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• PMA/PMN Number: K190387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2019
• 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