MAUDE Adverse Event Report: LIEBEL-FLARSHEIM BASE SYSTEM ILLU

Model Number	900006C
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
This case was reported by a facility in jinan, china on 27 august 2024.Reporter states that in the operating room, high-pressure injection angiography is performed when the patient is undergoing angiography surgery.However, the device reported an error, the operation failed, and the normal injection could not be carried out, resulting in increased blood loss for the patient.The standby machine was immediately used to successfully complete the operation, which extended the overall operation time and caused dissatisfaction among the patients' families.Hospital engineers rushed to the scene as soon as possible to detect and troubleshoot to find it's the internal motherboard problem.After dismantling the machine, repairing and sorting out the motherboard line, the equipment debugging and running normally.
Additional Manufacturer Narrative
Overall investigation summary: regional service spoke with customer who reported that after it was started, the system prompted "error 2003".Service remotely guided the customer on how the to clean the interior of the power head, removing debris from the linear pot.After it was cleaned, and the problem was resolved.The unit was functioning normally and was returned to service.A review of guerbet complaint tracking system (cts) showed no related complaint activity for this device.Impact assessment summary: no injury to the patient/user reported, imdrf codes: b13; c15; c1502; d02.Root / probable cause code: fluid ingress.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 remained in service.

• Brand Name: BASE SYSTEM ILLU
• Common Device Name: BASE SYSTEM ILLU
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: jacob miller ; 2111 e. galbraith rd; cincinnati 45237 ; 5139485765
• MDR Report Key: 20302311
• Report Number: 1518293-2024-00015
• Device Sequence Number: 8883529
• Product Code: DXT
• UDI-Device Identifier: 10746190002802
• UDI-Public: 0110746190002802
• 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: Other,Inspection
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 900006C
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown