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

Model Number	900001C
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Event or Problem Description
This case was reported by a facility in ningbo, china on 30 september 2024.Details of the case are as described below: injury: serious injury.Injury performance: the machine fell apart in-situ, the patient was far away so there was no injury but the patient was frightened, while the outer flesh of the thigh of the technician who operating the machine was subjected to strong friction, and other personnel were frightened instrument failure performance: high-pressure injector in normal use, suddenly "cut in half" fracture.Expected therapeutic disease or effect: for the successful implementation of renal artery embolization and accurate diagnosis and treatment of the patient's condition procedure of application: on (b)(6) 2024, during the embolization of the proper hepatic artery, needed to use a high-pressure injector to inject contrast agent through the blood vessel to make the local lesion developed under radiation.In the process of using the high-pressure injector, the working machine part of the high-pressure injector had "cut in half" fracture, and the patient was not physically harmed due to a certain distance from the machine, but was frightened.While the outer flesh of the thigh of the technician who operating the machine was subjected to strong friction, and the medical staff comforts the patient immediately; in order not to affect the smooth operation, the surgeon personally pushed the contrast agent under the ray, and the operation was delayed for about 10 minutes.Since then, contact the equipment section specialist and the engineer from the manufacture in time to feedback the fault, and the manufacturer arranges special personnel to repair the high pressure injector.If the machine is near the patient and the broken part falls in the direction of the patient, it will not only seriously affect theoperation of the patient, but also may cause serious additional harm to the patient.Event cause analysis: product cause (including instructions, etc.).Event cause analysis description: after the machine fell apart, the equipment section engineer inspected the machine on site and preliminarily concluded that the screw of the main body of the pillar machine fell off, resulting in the machine falling apart in-situ preliminary handling: in order not to affect the smooth operation, the surgeon personally pushed the contrast agent under the ray, and the operation was delayed for about 10 minutes.Contact the equipment section specialist and the manufacture engineer in time to feedback the fault, and the manufacturer will arrange special personnel to repair the high pressure injector.

• 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: 20558152
• Report Number: 1518293-2024-00016
• Device Sequence Number: 15693703
• 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
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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: 900001C
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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