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	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: the rn reports she primed the tubing with ns, placed it in the pump and closed the lever as normal.When the pump began to run, it squirted saline out from the cassette.The nurse repositioned the cassette thinking maybe it was not in correctly, but when she restarted the pump, the same thing happened.A preliminary review of the logs could not be performed.No sample or picture were available for analysis.Without the proper sample or picture evaluation is not possible to determine the probable root cause of the reported failure.Therefore, the customer complaint cannot be 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.The batch records fa23e02305 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.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: 23058354
• Report Number: 3014732157-2025-01009
• Device Sequence Number: 21024255
• Product Code: FPA
• UDI-Device Identifier: 00811505030054
• UDI-Public: 00811505030054
• 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
• 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 Expiration Date: 05/31/2026
• Device Model Number: SET-0013-1
• Device Catalogue Number: SET-0013-1
• Device Lot Number: FA23E02305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2024
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2023
• 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