MAUDE Adverse Event Report: ULRICH GMBH & CO. KG UL_INJECT; ULRICHINJECT CT MOTION PEDESTAL VERSION WITH HEATER AND BLUETOOTH

Model Number	XD 8000-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	04/04/2025
Type of Reportable Event	Death
Event or Problem Description
According to user information: "on (b)(6) 2025 at 11:45 a.M., ms.(b)(6) reported the death of a patient due to air in the heart in relation to (b)(6).A ct thorax abdomen examination with ultravist 300 in 500 ml glass bottles at a flow rate of 3ml/s with 21ml nacl / 100ml km / 30ml nacl.The contrast agent was not preheated.A 320 cm patient tube was used.Access was via a port system that is also used for chemotherapy.Ms.(b)(6) was unable to state the amount of air.The injector did not show any error messages.".

• Brand Name: UL_INJECT
• Common Device Name: ULRICHINJECT CT MOTION PEDESTAL VERSION WITH HEATER AND BLUETOOTH
• Manufacturer (Section D): ULRICH GMBH & CO. KG; buchbrunnenweg 12; ulm, baden-württemberg 89081 ; GM 89081
• Manufacturer Contact: andreas hilzenbecher ; buchbrunnenweg 12; ulm, baden-württemberg 89081 ; GM 89081
• MDR Report Key: 21948403
• Report Number: 9612420-2025-00102
• Device Sequence Number: 8534965
• Product Code: IZQ
• UDI-Device Identifier: 04052536002245
• UDI-Public: 04052536002245
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: XD 8000-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown