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	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported during internal testing: when an infusate with modifier(s) is deployed to the pump, and the user changes the name of the modifier or group, the modifier labels on the pump will not match the infusate deployed reports.The "deployed infusates" and "infusate - deployed status" reports will show the current modifier group and modifier label instead of the deployed labels.So, there is a mismatch between what is shown on the pump and what is shown on the ims reports.There is a mismatch between what is shown on the pump and what is shown on the ims deployed reports when it comes to modifier labels.If the user does not deploy the modifier labels after modification and selects to run a deployed infusates report, then the modifier names will not match with what is deployed to the pump.The expectation is that these reports show what has been deployed to the pump, and as these modifier item changes are also versioned in ims, then these should be aligned with what is shown on lvp.An active infusion was not stopped.Reporting as a conservative measure.No adverse effects were reported.Fresenius kabi is submitting a conservative report while assessing whether there is any clinical risk.
Event or Problem Description
There is a mismatch between what is shown on the lvp and what is shown on the ims deployed reports for modifier labels when an existing modifier is updated but is not deployed.The manage modifiers tool is used to configure modifiers in the drug library.If the user does not deploy modifier labels after modification and selects to run a deployed infusates report, there is a mismatch between the labels shown on the lvp and what is shown on the ims deployed reports.The expectation is that these reports show what has been deployed to the pump.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 negligible (occurrence of harm is improbable).

• 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: 21599746
• Report Number: 3014732157-2025-00201
• Device Sequence Number: 20899533
• 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; 030-0027-07
• 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: 02/21/2025
• 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