MAUDE Adverse Event Report: LIEBEL-FLARSHEIM BASE SYSTEM, ILLUMENA

Model Number	900001C
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Overall investigation summary a complaint was received on angioma illumena injector sn (b)(6) alleging that the injector would not inject the contrast medium.Additional information was requested, and it was reported that the doctor had to manually inject the contrast medium which resulted in a 20 minute delay in the procedure.Service engineers investigated and found an intermittent problem, which was caused by a loose connection of the interface cable (pn 900241), resulting in the user being unable to control the injector through the philips dsa.The interface cable was replaced, and the issue was resolved.A review of cts shows a similar cable connection issue reported on this system in october 2024 (ref: mk202410-0014) where the service engineer found that the same intermittent problem was due to a loose connection of the interface cable (pn 900241) on the power pack.Unlike in the current instance, the connection was only resecured, and the system returned to customer use.Impact assessment summary no injury to the patient/user reported imdrf codes: b01; c02, c0205; d02 root / probable cause code defective cable root / probable cause summary refer to investigation summary.No additional capa required at this time.Guerbet quality will continue to monitor and trend for similar issues.These trends and issues are reported on during quality metrics review and during the management reviews to consider input for additional corrective action.Disposition summary unit returned to service.
Event or Problem Description
This case was reported by a facility in (b)(6) china on 10 march 2025.Customer reports that on the afternoon of january 10, 2025, in the emergency dsa department, there was a need to rescue a patient who had fallen from a high place and suffered multiple fractures all over the body with bleeding from all the orifices of the head.Arterial embolization hemostasis treatment was carried out under the dsa machine.Suddenly, the high-pressure injector malfunctioned and could not inject the contrast medium.In an emergency, the doctor had to inject the contrast medium manually.Due to the high arterial pressure, the blood vessels were blurred and it was impossible to determine the bleeding situation.The malfunction of the high-pressure injector forced the doctor to inject the contrast medium manually, and the doctor could not leave the dsa room (originally there was no need to stay within the radiation range), so the medical staff received additional radiation, posing a safety risk.

• Brand Name: BASE SYSTEM, ILLUMENA
• Common Device Name: BASE SYSTEM, ILLUMENA
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: jacob miller ; 2111 e. galbraith rd; cincinnati, OH 45237 ; 5139485765
• MDR Report Key: 21753097
• Report Number: 1518293-2025-00009
• Device Sequence Number: 8235629
• Product Code: DXT
• UDI-Device Identifier: 10746190002796
• UDI-Public: 0110746190002796
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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: 900001C
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown