MAUDE Adverse Event Report: FRESENIUS KABI USA, LLC IVENIX, INC.; LVP PRIMARY ADMINISTRATION SET, SINGLE-INLET, LOW-SORBING (QTY 1)

Model Number	SET-0021-1
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	05/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: nurse reported: the ivf were leaking from the flow dial area.The patient's bed was wet.When you flush the tubing, the fluids leak from flow dial.Drug used: 0.9% ns sample available?: yes.A preliminary review of the logs identified the following issue: administration set leak (external part).Unknown if issue stopped an active infusion.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-0021-25.During the microscopic evaluation liquid drops were coming out of the ivenix unit from the resistor knob.An underwater leak test was performed, and a leak was detected, bubbles were observed coming from the flow dial area.During the autopsy of the resistor knob the seal was found positioned inverted on the pump side.The customer complaint is confirmed.The root cause could be related to improper placement of the seal (wafer side up).Also, the adjustment method used in primary lube was incorrect and lacked standardization following the mgs implementation, which led to insufficient detection sensitivity for improperly positioned seals due to the reduced translucency of the new cassettes.An internal investigation was opened to address this issue.The current process controls detection include 1) 100% leak and occlusion test is 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, 4) primary lube machine detects the correct position of the seal at the knob.The batch review could not be performed as the affected batch was not provided.

• Brand Name: IVENIX, INC.
• Common Device Name: LVP PRIMARY ADMINISTRATION SET, SINGLE-INLET, LOW-SORBING (QTY 1)
• Manufacturer (Section D): FRESENIUS KABI USA, LLC; 50 high street; suite 50; north andover MA 01845
• Manufacturer (Section G): FRESENIUS KABI LLC; 50 high street; suite 50; north andover MA 01845
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047-8930
• MDR Report Key: 22320520
• Report Number: 3014732157-2025-00691
• Device Sequence Number: 9024105
• Product Code: FPA
• UDI-Device Identifier: 00811505030108
• UDI-Public: 00811505030108
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/25/2025

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-0021-1
• Device Catalogue Number: SET-0021-1
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/25/2025
• 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