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	Obstruction of Flow (2423); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An infusion set up and off label use was reported.No patient harm was reported.No samples or pictures were returned for evaluation.The device was not returned to the service depot for further evaluation and possible repair.The following is the list of service activities: the customer reported an alarm, occlusion alarm, and an upstream occlusion alarm, the customer reported some upstream occlusion events experienced during attempted lutathera (radiopharmaceutical) infusions with the ivenix infusion system that appear to be related to infusion setup and off-label use, the lutathera ifu provides administration instructions only for use with a syringe pump and a peristaltic pump, as the ivenix lvp is a cassette-driven pump that uses ivenix administration sets, its use appears to fall outside the administration methods described in the lutathera ifu.The investigation results could not confirm the complaint as no product was returned; therefore, the complaint could not be confirmed or refuted.The root cause of the reported issue, infusion set up and off label use, could not be determined.An internal investigation was opened to address this issue.A history review of the fresenius kabi service records for reported serial number prior to the notification date of this complaint record found no same / similar issues related to this complaint.A device history review of the reported serial number was conducted by fresenius kabi and no related manufacturing nonconformance records were found.There were no other incidents in production of this product that would have caused the reported issue.All complaints are captured in tracking and trending and reviewed monthly to determine if additional investigation is required for further root cause analysis and any corrective actions.No action required at this time.

• 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; 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 dr; lake zurich, IL 60047
• MDR Report Key: 50351813
• Report Number: 3014732157-2026-03625
• Device Sequence Number: 12277953
• 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: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: FA26A22010
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown