MAUDE Adverse Event Report: FRESENIUS KABI USA, LLC IVENIX INFUSION SYSTEM; LARGE VOLUME PUMP (LVP) SOFTWARE

Model Number	5.10.2
Medical Device Problem Codes	Computer Software Problem (1112); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: biomed reported: "ticket stated "needs service " cleaned and ran infusion pump test.No alarms.Patient status unknown." pump serial number was reported to us (b)(6).A preliminary review of the logs identified the following issue: pump ceases operation due to sw error.(fresenius kabi has been able to identify the issue as a communication failure between application and flow processors resulting in a fail stop alarm) an active infusion was stopped.Reporting as a conservative measure.No adverse effects were reported.Additional information is needed to complete the investigation.
Event or Problem Description
Due to a software defect, there was a communication failure between the application and flow processors that resulted in a fail stop alarm.The lvp will enter a fail stop alarm and will need to be power-cycled to continue use.While it has not been reproduced, the defect in the code has been identified and an internal investigation has been created.

• Brand Name: IVENIX INFUSION SYSTEM
• Common Device Name: LARGE VOLUME PUMP (LVP) SOFTWARE
• 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 60047-8930
• MDR Report Key: 24379963
• Report Number: 3014732157-2026-00200
• Device Sequence Number: 18714450
• Product Code: FRN
• UDI-Device Identifier: 00811505030467
• UDI-Public: 00811505030467
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 5.10.2
• Device Catalogue Number: LVP-SW
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2024
• 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