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	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: biomed reported: "pump shut down and started alarming (red lights and audible alarm) while being programmed.Battery fully charged, disconnected from power source, cannot shut down, still alarming.Staff attempted to clean screen with alcohol without resolution.Pump currently in mb7-588 because it is still alarming! no patient harm noted" pump serial number: (b)(6) was running on sw ver 5.10.A preliminary review identified the following issue: pump ceases operation due to sw error an active infusion was not stopped.Reporting as a conservative measure.No adverse effects were reported.Additional information is needed to complete the investigation.
Event or Problem Description
Fresenius kabi lvp numeric input screens use shared code to enforce precision and value limits for parameters, with different numeric policies governing ranges of values.When input values exceed the allowed significant digits, the code attempts to truncate decimals (even if none exist) leading to incorrect formatting.This flaw causes the system to generate values with excessive decimal places, violating the permitted decimal length and triggering uncaught exceptions that crash the program.The issue is illustrated with examples where input strings like "0020" and "00060" are mishandled due to faulty assumptions in the truncation logic.The root cause is the code's assumption that excess significant digits always imply a decimal component that can be truncated, which is not always true.

• 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: 23687013
• Report Number: 3014732157-2025-01333
• Device Sequence Number: 5854831
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: 11/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3014732157-11/18/2025-00
• Patient Sequence Number: 1
• Patient Sex: Unknown