MAUDE Adverse Event Report: FRESENIUS KABI USA LLC IVENIX INFUSION SYSTEM; INFUSION MANAGEMENT SYSTEM (IMS)

Model Number	030-0027-06; 030-0027-07
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	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: during internal testing, there is a scenario where the lvp modifier menu may not display the modifier as shown in the infusion management system (ims).For example, if a modifier name was changed after infusates were deployed and then the user selectively deploys infusate(s) without selecting the option to "deploy all modifiers", there is a scenario where the ims and lvp become misaligned for infusates that were not marked as updated and/or selected to be deployed in the ims deployment manager.For those infusates(s) that are not deployed, the changed modifier is no longer displayed as an option on the lvp.The lvp and ims modifier menu are not aligned when the modifier is changed after deployment in a certain scenario.The lvp does not display the modifier's programming limit as an option in its modifier menu in the scenario when it has been changed in ims and then the user does not choose to "deploy all modifiers" and only selectively.An active infusion was not stopped.Reporting as a conservative measure.No adverse effects were reported.A defect risk assessment is currently being performed while investigating this issue.Fresenius kabi is submitting a conservative report while assessing whether there is any clinical risk.
Event or Problem Description
The lvp does not display the modifier's programming limit as an option in its modifier menu.The deployment manager tool is used to deploy the configured drug library to the lvp.Updating a modifier that is associated with multiple infusates and then selectively deploying some of the infusates results in a misalignment of the modifier for those infusates that were not deployed.The lvp does not display the modifier's programming limit as an option in its modifier menu due to multiple versions of the modifier.This issue does not adversely affect the pump.There is a potential incorrect infusate hazard.A defect risk assessment was completed at the end of march 2025.The risk has been categorized as acceptable with the severity of harm assessed as minor (occurrence of harm is remote).

• Brand Name: IVENIX INFUSION SYSTEM
• Common Device Name: INFUSION MANAGEMENT SYSTEM (IMS)
• 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: 21599745
• Report Number: 3014732157-2025-00200
• Device Sequence Number: 8266469
• Product Code: PHC
• UDI-Device Identifier: 00811505030443
• UDI-Public: 00811505030443
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: 030-0027-06; 030-0027-07
• Device Catalogue Number: 030-0027-06; 30-0027-07
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/09/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown