MAUDE Adverse Event Report: FRESENIUS KABI USA LLC IVENIX INFUSION SYSTEM; INFUSION SAFETY MANAGEMENT SOFTWARE

Model Number	030-0028-08
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	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: biomed reported: " this pump came to us stating pump problem could not duplicate, but it also has a funny rattle sound when the pneumatics fire.No lose item in pump just when the pneumatics fire it has a funny sound, but i am not getting pump problem." no patient incident reported.No other info.A preliminary review identified the following issue: pump ceases operation due to sw error.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
A coherence failure occurred due to air in cassette being detected at the exact time that backprime started.The pump did not function as intended since it entered a continuous backprime state when the user started the infusion.Backpriming should have stopped when the backprime alert was removed from the screen.This was reproduced during investigation by modifying the code to simulate what was seen in the logs.Attempting to reproduce the scenario manually failed to reproduce the same result after several hours of attempt.

• Brand Name: IVENIX INFUSION SYSTEM
• Common Device Name: INFUSION SAFETY MANAGEMENT SOFTWARE
• 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 ; 8475502913
• MDR Report Key: 24298847
• Report Number: 3014732157-2026-00173
• Device Sequence Number: 10153496
• Product Code: PHC
• UDI-Device Identifier: 00811505030467
• UDI-Public: 00811505030467
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 030-0028-08
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2024
• 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