MAUDE Adverse Event Report: Fresenius Kabi AG Ivenix Infusion System; Set, Administration, Intravascular

Model Number	SET-0032-1
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
When putting cassette into the pump it was noted that the cassette was leaking out of the pump onto the floor.

• Brand Name: Ivenix Infusion System
• Common Device Name: Set, Administration, Intravascular
• Manufacturer (Section D): Fresenius Kabi AG; three corporate drive; lake zurich IL 60047
• MDR Report Key: 50754638
• Report Number: 50754638
• Device Sequence Number: 13149295
• Product Code: FPA
• UDI-Device Identifier: 00811505030214
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2026
• Report Date (Section F): 07/27/2026

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
• Device Model Number: SET-0032-1
• Device Catalogue Number: SET-0032-1
• Device Lot Number: FA26A29023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 07/27/2026