MAUDE Adverse Event Report: FRESENIUS KABI USA, LLC Ivenix Infusion System; LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual

Model Number	SET-0032-01
Medical Device Problem Codes	Leak/Splash (1354); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction

• Brand Name: Ivenix Infusion System
• Common Device Name: LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual
• Manufacturer (Section D): FRESENIUS KABI USA, LLC; 50 high street; suite 50; north andover MA 01845
• Manufacturer (Section G): Fresenius Kabi LLC; 50 high street; suite 50; north andover MA 01845
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047--893
• MDR Report Key: 50915526
• Report Number: 3014732157-2026-03987
• Device Sequence Number: 12098455
• Product Code: FPA
• UDI-Device Identifier: 00811505030214
• UDI-Public: 00811505030214
• 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
• Report Date (Section B): 09/28/2026

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-0032-01
• Device Catalogue Number: SET-0032-01
• Device Lot Number: FA26B05021
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2026
• 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
• Patient Sex: Unknown