MAUDE Adverse Event Report: FRESENIUS KABI USA LLC IVENIX, INC.; LVP BLOOD PRODUCTS ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, Y-SITE, MESH FIL

Model Number	SET-0014-1
Medical Device Problem Codes	Leak/Splash (1354); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: nurse reported: 3 different items of the same lot # (fa25c03165) leaking blood product into the pump.As a result, we wasted blood product.A preliminary review identified the following issue: administration set leak (external part).Unknown if an active infusion was stopped.Reporting as a conservative measure.No adverse effects were reported.Additional information is needed to complete the investigation.

• Brand Name: IVENIX, INC.
• Common Device Name: LVP BLOOD PRODUCTS ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, Y-SITE, MESH FIL
• 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: 25503712
• Report Number: 3014732157-2026-02813
• Device Sequence Number: 10544162
• Product Code: FPA
• UDI-Device Identifier: 00811505030030
• UDI-Public: 00811505030030
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/23/2026

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: SET-0014-1
• Device Catalogue Number: SET-0014-1
• Device Lot Number: FA25C03165
• 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: 06/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown