MAUDE Adverse Event Report: FRESENIUS KABI USA LLC IVENIX, INC.; LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT

Model Number	SET-0013-1
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	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: manager reported: "magnesium running, noticed puddle of liquid under the pump.Stopped med and noticed magnesium leaking from the bottom of cassette.Stopped infusion than changed tubing." patient harm: no.Active infusion stopped: yes.Drug: magnesium.A preliminary review identified the following issue: administration set leak (external part).An active infusion was stopped.Reporting as a conservative measure.No adverse effects were reported.Additional information is needed to complete the investigation.
Event or Problem Description
One sample of ivenix administration set was returned for evaluation.No defects were observed during visual inspection.The gold foil corresponded to the specific code set-0013-25.Microscopic examination revealed that the edge of the diaphragm was not properly positioned and was displaced towards the flat area of the diaphragm.During the priming process, liquid drops were coming out of the ivenix unit.The kit could not be installed on the ivenix pump due to the mentioned defect.An underwater leak test was performed to verify the liquid and air side areas of cassette and bubbles were observed coming from unit.Finally, a dye test was performed, and the ink spilled over all the ivenix cassette.The customer complaint is confirmed.The probable root cause is related to a manufacturing error during the positioning of the diaphragm, leading to it being displaced.A nest fixture was created to improve diaphragm assembly accuracy, a magnifier lamp (white light) was added to ensure correct diaphragm placement, and units were inspected before and after welding.These actions were implemented on 04/25/2025 to mitigate this issue.The current process controls detection include 1) 100% leak and occlusion test are performed through the leak and occlusion test machine in order to capture units with any blockage or leak failure mode, 2) quality sampling for final physical testing, for performing a flow and underwater leak tests, 3) 100% visual inspection during the manufacturing process and final physical inspections.The batch record fa25a16013 was reviewed.No exceptions were generated that could classify as a possible root cause of this defect.The finished good lot has passed all sampling acceptance criteria for all tests performed including in-process testing and product testing.

• Brand Name: IVENIX, INC.
• Common Device Name: LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT
• 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: 22862365
• Report Number: 3014732157-2025-00904
• Device Sequence Number: 13076053
• Product Code: FPA
• UDI-Device Identifier: 00811505030054
• UDI-Public: 00811505030054
• 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): 10/16/2025

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
• Device Model Number: SET-0013-1
• Device Catalogue Number: SET-0013-1
• Device Lot Number: FA25A16013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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