MAUDE Adverse Event Report: Fresenius Kabi USA LLC Ivenix Infusion System; Large Volume Pump (LVP)

Model Number	LVP-0004
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: biomed reported: continuous beeping and flashing a red light.Screen was showing an error message, but it was not recorded.Touch screen was unresponsive.Unit was forced to shut down by holding down the power button for 1 minute.Turned on after and behaved normally, however still sending to vendor to investigate previous unusual behavior.A preliminary review identified the following issue: processor hardware failure (linux core) an active infusion was 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: Large Volume Pump (LVP)
• 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: 50947863
• Report Number: 3014732157-2026-04017
• Device Sequence Number: 13349387
• Product Code: FRN
• UDI-Device Identifier: 00811505030320
• UDI-Public: 00811505030320
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/30/2026

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: LVP-0004
• Device Catalogue Number: LVP-0004
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown