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

Model Number	900001C
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Overall investigation summary: a complaint was received on angiomat illumena injector 900001c serial number: (b)(6) alleging that it failed to inject as instructed, resulting in frequent interruptions to the surgery causing delays in the surgery and patient treatment.The initial report indicated that the connecting cable between the injector and the dsa was not properly installed.A guerbet trained service rep went onsite to investigate and confirmed that the interface cable pn: 900251-3 had become damaged causing the dsa start signal not to be received by the injector.Service engineer repaired the damaged connection of the interface cable and the problem was resolved.The system was tested for proper operation and returned to customer use.There was no reported issue with the illumena injector.A review of guerbet complaint tracking system (cts) showed no previously reported complaint activity for this device.Impact assessment summary: no injury to the patient/user, but a delay in procedure was 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 dongyang, china on 05 march 2026.The customer states that on (b)(6) 2025, during surgery in the interventional catheterization room, the high-pressure injector failed to inject the drug as instructed, resulting in frequent interruptions to the surgery, failure to complete the surgery as scheduled, and delays in the surgery and patient treatment.The high-pressure injector failed to inject the drug as instructed as the injector had no response.

• Brand Name: BASE SYSTEM, ILLUMENA
• Common Device Name: BASE SYSTEM, ILLUMENA
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati
• Manufacturer Contact: jacob miller ; 2111 e. galbraith rd; cincinnati, OH
• MDR Report Key: 24730449
• Report Number: 1518293-2026-00021
• Device Sequence Number: 9287007
• 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): 03/30/2026

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: 03/05/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown