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	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Rn was setting up an infusion when the pump began alarming, the touch screen was frozen and was not responsive.Took multiple attempts to force a hard shutdown.Lvp serial number: (b)(6).A review of the device logs indicates that the clinical application user interface froze during infusion programming due to software defect.Lvp entered fail stop alarm state.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
A user at the customer reported a pump with a frozen screen, annunciating an alarm condition.Through examination of the logs, and further engineering investigation it was determined that if a user enters a rate with 2 leading zeros (eg.0010) on the set rate screen, which triggers a guidance alert, and then the user presses the back button on the alert, the clinical application freezes.Rebooting the pump is the only workaround.A software component was found to be the source of the issue.Fresenius kabi plans on addressing this issue via a future sw release.

• 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: 22661822
• Report Number: 3014732157-2025-00826
• Device Sequence Number: 3677686
• 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): 09/04/2025

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: 07/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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