MAUDE Adverse Event Report: Fresenius Kabi USA, LLC Ivenix Infusion System; Large Volume Pump (LVP)

Model Number	LVP-0004
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: there is a crack on bottom-left of the front enclosure.A preliminary review of the device logs was not performed.The device was returned for evaluation.The front housing is damaged on the left side bottom corner and extending from the handle assembly to front face.During investigation it was found the cycle counts on the batteries were high (>115).While the batteries are not a source of failure at this time, they will be removed and replaced with new batteries.A broken screw mount was identified.Braided wire was present instead of insulated wire.The bag hook was missing.The lip seals had debris.During repair, the device experience a failing dsps calibration test (gain out of range).The dsps sensor was removed and replaced.The dsps calibration test was performed and the unit passed.After repair, the device passed all functional testing.An active infusion was not stopped.Reporting as a conservative measure for the downstream pressure sensor issue identified during investigation.No adverse effects were reported.

• Brand Name: Ivenix Infusion System
• Common Device Name: Large Volume Pump (LVP)
• 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 ; +1(847)550-2300
• MDR Report Key: 50899074
• Report Number: 3014732157-2026-04012
• Device Sequence Number: 6026594
• Product Code: FRN
• UDI-Device Identifier: 00811505030320
• UDI-Public: 00811505030320
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K183311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: LVP-0004
• Device Catalogue Number: LVP-0004
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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