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	05/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
N/a.
Event or Problem Description
The following has been reported: nurse reported: "rn called cis to bedside for issue with infusing blood.Blood set described to have been primed appropriately via backprime on the pump.Witnessed continuous upstream occlusion alarm.Rn attempted to troubleshoot via backprime which also maintained continuous occlusion.Attempted to prime blood product manually using flow dial (disconnected from patient) and prbcs very slow to advance.Attempted to infuse on a different pump with same alarm.Changed to a new blood set and successfully primed/infused blood.Continuous occlusion alarm.Resolved by changing to new admin set.Drug used: prbc.Patient harm: no".As it was full of a blood product it had to be discarded.A preliminary review of the logs identified the following issue: tubing set error (clogged admin set).An active infusion was not stopped.Reporting as a conservative measure.No adverse effects were reported.Additional information is needed to complete the investigation.

• 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 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: 25233827
• Report Number: 3014732157-2026-02235
• Device Sequence Number: 5105379
• Product Code: FPA
• UDI-Device Identifier: 00811505030030
• UDI-Public: 00811505030030
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/28/2026

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: FA25B17134
• 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: 05/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• 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