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	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: customer reported: nurse reported, iv tubing leak after its put into the pump.Customer had two tubings (unsure of lot #) that were not leaking and were able to flow by gravity and then once put in the pump the liquid was coming out and flowing down the tubing.A preliminary review 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
No sample or picture were available for analysis.Without the proper sample or picture, an evaluation is not possible to determine the probable root cause of the reported failure.Therefore, the customer complaint cannot be confirmed.The most probable root cause of the reported incident is related to defective tubing with breaks or cuts located in the tubing, separation from the cassette port or leaks coming from the cassette port.An internal investigation was opened to mitigate the reported failure.The current process controls detection includes 1) post sterilization sampling final inspection, 2) the first piece inspection will be performed to the first final assembled kit manufactured per shift.This kit will be submitted to visual inspection as per the classification of defects included in this specification and as per the applicable drawing, 3) 100% visual inspection is performed in manufacturing line, 4) 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.

• 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 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: 21610025
• Report Number: 3014732157-2025-00168
• Device Sequence Number: 18081522
• Product Code: FPA
• UDI-Device Identifier: 00811505030108
• UDI-Public: 00811505030108
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/08/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/08/2025
• 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