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	02/24/2026
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: the device has an inoperative power board.Please note - this is not a customer device.Its from a lot of agilia syringe pumps that were at the pleasant prairie warehouse in need of pms.Once the repair and pm is complete it will be returned to the pleasant prairie warehouse.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 history log was reviewed.Technical errors 54 and 99 related to the reported event were found.The device was received in lake zurich for preventive maintenance during which our local technical team found an error 54.The reported devices were not sent back to brézins for investigation as repairs were performed locally.According to provided information, device will power on but only displays coulombmetre error 54.Replacing battery does not resolve issue.This device is not owned by a customer and has been stored in the pleasant prairie warehouse for several years.Replacing power board resolved coulombmetre error 54.Therefore, the power supply board was replaced and sent back to brézins for further investigation.Once in brézins, a visual control was performed and nothing was noticed.This is the original board.This complaint is considered as valid and the root cause is linked to a defective display board.It could be that this is only a connection problem between the power supply and cpu boards already seen in production.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 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
• Manufacturer (Section G): FRESENIUS VIAL S.A.S.; le grand chemin; brezins, 38590 ; FR 38590
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; 8475502913
• MDR Report Key: 24489672
• Report Number: 3000240707-2026-00076
• Device Sequence Number: 18812726
• Product Code: FRN
• UDI-Device Identifier: 04086000856058
• UDI-Public: 04086000856058
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K121613
• 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): 04/21/2026

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: Z018735
• Device Catalogue Number: Z018735
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown