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	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: the unit was returned during service after initial complaint investigation was completed for lever arm issues.Secondary findings: secondary findings: outlet fva pin stuck in due to excess debris.Fva pin lip seals will be replaced during repair.

• 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--893 ; +1(847)550-2913
• MDR Report Key: 50942192
• Report Number: 3014732157-2026-04134
• Device Sequence Number: 10739970
• Product Code: FRN
• UDI-Device Identifier: 00811505030320
• UDI-Public: 00811505030320
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Operator of Device: Other
• Device Model Number: LVP-0004
• Device Catalogue Number: LVP-0004
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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