MAUDE Adverse Event Report: FRESENIUS VIAL S.A.S. AGILIA SP MC WIFI US; INFUSION PUMP SYSTEM

Model Number	Z018735
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: customer sent in request form reporting unit needs a pm and it is giving an error code.Customer has confirmed that information regarding an ae is unknown.Device history record was reviewed and nothing was found related to the reported event.Partial device history log was reviewed.Several technical errors 22 were found which confirms the reported event (force sensor issue).The reported device was received in lake zurich and its investigation was performed by our local technical team.According to provided information, nothing was noticed during both external and internal check.Several functional tests related to the reported event were carried out.All performed successfully and values were found compliant with ifu specifications compared to settings.The reported event could not be reproduced.Error 22 on the agilia connect range is a known issue for which an internal capa was opened to reduce the occurrence of this error.The investigation into this error showed that it was mainly due to a faulty force sensor.The serial number of the pump ((b)(6)) indicates that it is within scope of this capa, which states to replace the force sensor.This complaint has been added to our trend for statistical monitoring.To our knowledge this complaint is not being related to patient safety.This complaint is considered as: valid.

• Brand Name: AGILIA SP MC WIFI US
• Common Device Name: INFUSION PUMP SYSTEM
• Manufacturer (Section D): FRESENIUS VIAL S.A.S.; le grand chemin; brezins, 38590 ; FR 38590
• MDR Report Key: 23527620
• Report Number: 3004548776-2025-00582
• Device Sequence Number: 9084276
• Product Code: FRN
• UDI-Device Identifier: 04086000856058
• UDI-Public: 04086000856058
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2025
• Report Date (Section F): 11/11/2025

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
• Operator of Device: Other
• Device Model Number: Z018735
• Device Catalogue Number: Z018735
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/16/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/11/2025