MAUDE Adverse Event Report: FRESENIUS KABI USA LLC IVENIX, INC.; LVP BLOOD PRODUCTS ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, Y-SITE, MESH FIL

Model Number	SET-0014-1
Medical Device Problem Codes	Obstruction of Flow (2423); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: customer reported: "nurse kept receiving upstream occlusion alarm when backpriming, despite clamp being open, red cap removed.No blood bag hooked up initially - just trying to backprime line.They fumbled with it' for ~20 min including attaching the blood bag to also try to backprime with no success.Once they tried a new blood admin set, it worked fine.Tubing not saved due to blood being in the line.A preliminary review identified the following issue: unresolved occlusion alarms an active infusion was not stopped.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 is available for analysis.Without the proper sample or picture evaluation is not possible to determine the probable root cause of the reported failure.The customer complaint cannot be confirmed.The potential root cause of the reported issue could be 1) an upstream occlusion alarm is triggered when the lvp cannot fill the ipc (pumping chamber) of the administration set due to the inlet tubing of the set being kinked or the slide clamp being actuated on the tubing, 2) small syringes can sometimes cause this to trigger when infusing from the secondary access port (through the secondary lav), 3) spike was not inserted correctly into the solution bag, 4) a possible cause could be excessive welding used to join internal components of the cassette.If an administration set triggers this alarm without the tubing being kinked/clamped or without infusing through a small syringe (5 cc), there could be an issue with the administration set that needs to be investigated.No sample is available for evaluation.Therefore, reported failure could not be replicated and exact root cause could not be provided.The current process controls detection include 1) 100% leak and occlusion test is performed through the leak and occlusion test machine to capture units with any blockage or leak failure mode, 2) quality sampling for final physical testing, for performing flow and underwater leak tests, 3) 100% visual inspection related to kinks during the manufacturing process and final physical inspections.The batch record fa25a21021 was reviewed.Record #2035473 was generated related to a unit found with the secondary port blocked, causing a failure in the functional (occlusion) test.The finished good lot has passed all sampling acceptance criteria for all tests performed including in-process testing and product testing.

• Brand Name: IVENIX, INC.
• Common Device Name: LVP BLOOD PRODUCTS ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, Y-SITE, MESH FIL
• 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: 24845136
• Report Number: 3014732157-2026-00435
• Device Sequence Number: 17589942
• Product Code: FPA
• UDI-Device Identifier: 00811505030030
• UDI-Public: 00811505030030
• 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): 04/30/2026

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-0014-1
• Device Catalogue Number: SET-0014-1
• Device Lot Number: FA25A21021
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2025
• 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