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

Model Number	Z019735
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported by customer: service order was originally created for preventative maintenance but during pm, an issue was found.3 year preventative maintenance - customer sent in the attached request form reporting a maintenance message on screen of all pumps.Dates range from july to september.Reporting as a conservative measure.Adverse effects were not reported.Additional information is needed to complete the investigation.
Event or Problem Description
Device history record was reviewed and nothing was found related to the reported event.Device log was reviewed, several pressure sensor alarms the device was received in lake zurich for preventive maintenance during which our local technical team found a failure of the calibration of the downstream pressure sensor.The reported devices were not sent back to brézins for investigation as repairs were performed locally.According to provided information, the calibration of downstream pressure sensor failed.After the replacement of the pressure sensor, the cpu board found inoperative.Therefore, the downstream pressure sensor was replaced and sent back to brézins for further investigation.Once in brézins, a visual control was performed and nothing was noticed.Following visual inspection, cross-tests were performed.The downstream pressure sensor was installed in a test device.The tests device is connected to partner software to calibrate the pressure sensor.After validating step 1, nothing is displayed on the screen, then error 42 triggered.The reported event is considered as valid, and the root cause is likely due to a defective downstream pressure sensor.To our knowledge this complaint is not being related to patient safety.This complaint is considered as: valid.The trend is: normal.

• Brand Name: AGILIA VP 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: 23694440
• Report Number: 3004548776-2025-00607
• Device Sequence Number: 9211179
• Product Code: FRN
• UDI-Device Identifier: 04086000856089
• UDI-Public: 04086000856089
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 03/09/2026
• Report Date (Section F): 03/09/2026

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
• Operator of Device: Other
• Device Model Number: Z019735
• Device Catalogue Number: Z019735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/19/2025
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 03/09/2026
• 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: 03/09/2026