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	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: tonight, we had a patient on a chemo regimen and the nurse reported leaking from the cassette that is in the primary tubing.The drug had been running for a short time 2hrs when it was discovered and the nurse reports an estimated 3 drops of leakage seen but could have been more as the patient was moving around.We did stop the drip re-mix and give them a new bag to hang as we could not be sure if sterility was compromised.The regimen is a combination bag of etoposide/doxorubicin/vincristine that runs continuously over 24hrs for 5 days.The patient was started on the regimen on (b)(6) 2023 and today is the 3rd day of therapy so 3rd bag to be hung.Earlier today with the 2nd bag that had been running we also did have some leaking from the filter which was separate site.A preliminary review of the logs could not be performed.No samples or pictures available for evaluation.Therefore, it is not possible to replicate or confirm the reported issue.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.The in-process leak testing process failed to detect the leak at manufacturing facility.Current controls include 100% leak testing performed by a leak tester and 100% visual inspection of the unit at manufacturing lines.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: 23058357
• Report Number: 3014732157-2025-01004
• Device Sequence Number: 8766142
• 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 Model Number: SET-0013-1
• Device Catalogue Number: SET-0013-1
• 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: 12/21/2023
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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