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

Model Number	030-0028-08
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During internal testing at fresenius kabi with one soaker pump, the ui froze and logs contained a repeated network error message.This occurred after das performed it maintenance (incl.But not limited to rebooting dns servers).These are the only two data points for ascertaining the root cause of the freeze.Reproduction has not been possible so far.Attempts at reproduction thus far include: * rerunning the squish test originally running on the affected pump for many days * creating a wifi network to recreate dhcp lease limitations found on ivx-lvp * creating a wifi network to redirect dns, mimicking das maintenance the behavior which prompted the creation of this complaint has not been reproduced despite numerous attempts, and it has not manifested otherwise since first observation.The root cause of this cannot be determined because reproduction has proven infeasible.If this behavior occurred in the field the clinicians ability to manage infusions would be impacted due to the user interface freezing.Reporting due to the referenced technical issue; no adverse effects or serious injuries were reported.More information is needed to complete the investigation.
Event or Problem Description
It has been determined that if the ui becomes unresponsive, the clinician will be unable to provide therapy via the lvp.As the issue has not been able to be replicated, (b)(6) has not been able to identify what specific code would need more resiliency.To date, this issue has only been experienced once during internal testing, has not been able to be replicated and has never been experienced in the field by an end user.(b)(6) will reopen investigation if the symptoms occur again.

• 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 60047-8930 ; 8475502913
• MDR Report Key: 21876545
• Report Number: 3014732157-2025-00321
• Device Sequence Number: 15638845
• Product Code: PHC
• UDI-Device Identifier: 00811505030467
• UDI-Public: 00811505030467
• 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): 04/30/2025

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
• Operator of Device: Other
• Device Model Number: 030-0028-08
• Device Catalogue Number: LVP-SW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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