MAUDE Adverse Event Report: FRESENIUS KABI USA LLC IVENIX, INFUSION SYSTEM; LVP PRIMARY ADMINISTRATION SET, SINGLE-INLET, LOW-SORBING (QTY 1)

Model Number	SET-0021-01
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: nurse reported : there was a malfunction with iv tubing for a dobutamine stress test.Dobutamine started and kept receiving an error message that cassette was not loaded properly.Cassette reloaded four times but still received the error message.Upon further inspection found the cassette was cracked and leaking.Patient injury/adverse reaction : no.Stopped active infusion : no.Occurred : before use.Drug used : n/a.Incident type : error / crack/ leak.Action taken : n/a.A preliminary review identified the following issue: administration set breaks (any 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
No sample or picture were available for analysis.Without the proper sample or picture evaluation it is not possible to determine the probable root cause of the reported failure.The customer complaint cannot be confirmed.The potential root causes of the leak from the cassette could be related to 1) misplaced diaphragm which resulted in a leak when the diaphragm was actuated by the valve pins in the pump, 2) an incorrect and poor sealing of the cassette in the welder machine causing the reported leakage, 3) over-insertion of the secondary port which caused a crack at the cassette, 4) cassette seal not assembled correctly causing a leak in the flow dial.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, INFUSION SYSTEM
• 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: 21960291
• Report Number: 3014732157-2025-00469
• Device Sequence Number: 21129407
• 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): 06/23/2025

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-0021-01
• Device Catalogue Number: SET-0021-01
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/23/2025
• 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