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	Leak/Splash (1354); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: nurse reported: cassette leaking from the bottom, gold squares are also not aligned.Patient had dexmedetomidine infusing.Rn noticed moderate size puddle on the floor.Source of leak was noted to be coming from iv tubing cassette.Pump did not alarm for any malfunction.New medication and tubing hung.Old tubing given to cns.Result: needed to get different tubing.- process occurred: before treatment.- injury/adverse reaction: no.- stop active infusion: no.- resulted in under/over-infusion: no.- drug used for infusion: not sure.A preliminary review of the logs identified the following issue: administration set leak (external part).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
One sample of an ivenix administration set was returned for evaluation.No defects were observed during visual inspection per the applicable drawing.The gold foil were as corresponded to the specific code (b)(6).Primary line infusion passed successfully and was tested with a set rate of 0.5ml/hr and set volume of 0.1ml and primary line was connected to a saline solution bag.An underwater leak test was performed and a leak was detected; bubbles were observed coming from the flow dial.During the microscopic examination a bad welding was revealed between the retainer and seal.The customer complaint is confirmed.The reported leak could be related to poor welding of the cassette.An internal investigation was opened to mitigate the reported 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.

• 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 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: 21876709
• Report Number: 3014732157-2025-00352
• Device Sequence Number: 7766095
• 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): 05/21/2025

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: 04/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/21/2025
• 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