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

Model Number	Z021135
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported by customer: damage to front locking mechanism customer sent in the request form reporting: damage to front locking mechanism for tubing.Action taken: received pump (b)(6).Confirmed customer reported issue.The door locking mechanism was found to be damaged, and the door assembly was replaced.Additionally, the lcd display backlight was inoperative; as a result, the display was replaced.The air sensor failed calibration and was also replaced.A full calibration was performed on the device.Equipment cleaned, post service tested and released for use.Reporting as a conservative measure.Adverse effects were not reported.Additional information is needed to complete the investigation.Device history record was not reviewed as the device has already gone through its first preventive maintenance.Device log was reviewed, no error or issue linked to the reported event was found.The reported device was received in lake zurich and its investigation was performed by our local technical team.During this investigation, the screen was found very dim, back light was not functioning.This complaint is considered as valid, dim screen is due to ageing, device was manufactured in 2015.To our knowledge this complaint is not being related to patient safety this complaint is considered as: valid.The trend is: normal.

• Brand Name: VOLUMAT MC AGILIA 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: 25375229
• Report Number: 3000240707-2026-00207
• Device Sequence Number: 18780756
• Product Code: FRN
• UDI-Device Identifier: 04086000851794
• UDI-Public: 04086000851794
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 06/03/2026

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: Z021135
• Device Catalogue Number: Z021135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• 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