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	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: non-chemo fluid leaking from the back of the cassette.No patient harm.Delayed patient infusion by 15-20 minutes.A preliminary review of the logs could not be performed.One sample of ivenix administration set was returned for evaluation.During the visual inspection it was observed that the set was assembled correctly per the applicable drawing.Primary line infusion did not pass successfully and was tested with a set rate of 0.5ml/hr and set volume of 1.5ml.A leak coming from inside of the cassette was observed and alarm tubing set problem was replicated twice in the ivenix infusion machine.An underwater leak test was performed for verifying the liquid side area of cassette and bubbles were observed coming from unit.An underwater leak test was performed for verifying the air side area of the cassette and no bubbles were detected.A dye test was performed, and it was observed that the leak was coming from the outlet valve.The customer complaint is confirmed.The leak in cassette could be potentially related to a misplaced diaphragm which resulted in a leak when the diaphragm was actuated by the valve pins in the pump.In addition, it could be related to an incorrect and poor sealing of the cassette in the welder machine causing the gap and reported leakage.Fresenius kabi has performed a retrospective review of complaints associated with this failure mode and has decided to submit an mdr as a conservative measure.No adverse effects were reported.

• 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: 23058356
• Report Number: 3014732157-2025-01001
• Device Sequence Number: 12953326
• Product Code: FPA
• UDI-Device Identifier: 00811505030054
• UDI-Public: 00811505030054
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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