MAUDE Adverse Event Report: Fresenius Kabi USA LLC Ivenix Infusion System; LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Fil

Model Number	SET-0014-1
Medical Device Problem Codes	No Apparent Adverse Event (3189); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following has been reported: customer reported: patient that needed blood products, went through 5 blood tubing lines, 6 different pumps because the pumps kept staying the line was not able to be read in the pump.A preliminary review identified the following issue: set not recognized.An active infusion was not stopped.Reporting as a conservative measure.No adverse effects were reported.Additional information is needed to complete the investigation.

• Brand Name: Ivenix Infusion System
• Common Device Name: LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Fil
• Manufacturer (Section D): Fresenius Kabi USA LLC; 50 high street; suite 50; north andover MA 01845
• Manufacturer (Section G): Fresenius Kabi USA LLC; 50 high street; suite 50; north andover MA 01845
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; +1(847)550-2913
• MDR Report Key: 50013374
• Report Number: 3014732157-2026-03349
• Device Sequence Number: 10547482
• Product Code: FPA
• UDI-Device Identifier: 00811505030030
• UDI-Public: 00811505030030
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K183311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2026

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-0014-1
• Device Catalogue Number: SET-0014-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Disability
• Patient Sex: Unknown