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

Model Number	SET-0021-1
Medical Device Problem Codes	No Apparent Adverse Event (3189); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Related report numbers: 3014732157-2026-00295 3014732157-2026-00296 3014732157-2026-00297 3014732157-2026-00298 3014732157-2026-00299 3014732157-2026-00300 3014732157-2026-00301 3014732157-2026-00302 3014732157-2026-00303 3014732157-2026-00304.3014732157-2026-00306.
Event or Problem Description
The following has been reported: nurse reported: "shortly after starting and at several times during the infusion air in line alarms detected causing the infusion to stop until cleared.No air was present during priming but formed after.No visible air or bubbles in the tubing proximal to the cassette.During procedure this caused the provider to troubleshoot including disconnecting several times to remove air.With no de-airing port it must be disconnected from the patient causing disruption and changes to care.This is an acute change from 2mos ago.This happened 12 times today and have 1 sample available.Patient harm: no.Several instances where air-in-line alarms were impacting the anesthesia practice.These air issues have caused infusions to stop, and additional interventions needed to keep the case progressing, as the flow of medication including propofol was interrupted.They have had this happen so far 12 times today on various pumps, and there are estimated several dozen instances of this recently.They have not made any other changes to practice, the only change identified is the newest lot numbers.A preliminary review identified the following issue: air in line alarms (unresolved) an active infusion was stopped.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.Primary line infusion passed successfully and was tested with a set rate of 1000ml/hr and set volume of 10ml and primary line was connected to a saline solution bag.The primary bolus prime process passes successfully.Under microscope, no defects were observed at the administration cassette.The customer complaint is not confirmed.The root cause could not be determined.The evaluation methods applied to the returned sample were not able to identify the origin of the reported defect air in line alarm.No visible defects were observed in the unit.Defect probably related to medicine or liquid substance used by the customer.The current process controls detection includes 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.The batch record fa25l17165 was reviewed.No exceptions were generated that could classify as a possible root cause of this defect.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 PRIMARY ADMINISTRATION SET, SINGLE-INLET, LOW-SORBING
• 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: 24681623
• Report Number: 3014732157-2026-00305
• Device Sequence Number: 10042131
• 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): 04/27/2026

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-0021-1
• Device Catalogue Number: SET-0021-1
• Device Lot Number: FA25L17165
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2025
• 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