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

Model Number	Z021135
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported by customer: pump infused medication at fast rate.Customer emailed in the request form reporting: pump infused medication at rate faster than it was programmed for.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.No event linked with the reported issue was observed.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.According to provided information, nothing was noticed during both external and internal check (except the externals, internals and inseams found dirty).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.Based on available information, this complaint is considered as not valid with no issue.To our knowledge this complaint is not being related to patient safety.This complaint is considered as: not valid.The trend is: n/a.

• 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: 24220856
• Report Number: 3000240707-2026-00023
• Device Sequence Number: 8196899
• Product Code: FRN
• UDI-Device Identifier: 04086000851794
• UDI-Public: 04086000851794
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/17/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2017
• 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