MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MRXPERION MR INJECTION SYSTEM

Model Number	87838420
Medical Device Problem Codes	Unintended System Motion (1430); Unintended Movement (3026); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation remains in progress.Once the investigation is completed, a follow-up report will be submitted.
Event or Problem Description
A bayer service representative was on site to install a new medrad® mrxperion injection system in a new mri suite.A screwdriver that the representative was using was pulled into the canon magnet bore.The tool was able to be removed without having to ramp down the magnet.No injury or adverse event was reported.
Event or Problem Description
A bayer service representative was onsite to install a new medrad® mrxperion injection system in a new mri suite.A screwdriver that the representative was using was pulled into the canon magnet bore.The tool was able to be removed without having to ramp down the magnet.No injury or adverse event was reported.
Additional Manufacturer Narrative
A bayer field service representative was onsite at the hospital to install a new medrad® mrxperion injection system.During installation, a ferrous screwdriver was inadvertently brought into the scan room and was subsequently drawn into the magnet bore.This, in turn, caused some cosmetic damage to the scanner cover which bayer is paying to replace for the customer.The screwdriver was able to be removed from the magnet without having to ramp down/quench the magnet.Bayer product analysis interviewed the field service manager and confirmed that all bayer field service representatives who work in an mr environment receive mr training annually.This mri safety training clearly states that ferrous tools are not to be used in an mri suite.Bayer further confirmed that the representative who was performing this installation had completed the required training and remains up-to date.Therefore, our investigation concluded that the incident occurred due to user error during injector installation by the bayer employee which will be addressed directly with this employee.Additionally, further evaluation will take place via bayer's capa (corrective and preventive actions (capa) process.

• Brand Name: MRXPERION MR INJECTION SYSTEM
• Common Device Name: MRXPERION MR INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer Contact: diane eckert ; one bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 22227019
• Report Number: 2520313-2025-00014
• Device Sequence Number: 15542635
• Product Code: DXT
• UDI-Device Identifier: 00616258025094
• UDI-Public: (01)00616258025094(11)250130
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K143538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 87838420
• Device Catalogue Number: MRXPERION
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown