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	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported by customer: air in line error customer reporting air in line error-reported trying to clear several times and error would not clear.Reporting as a conservative measure.Adverse effects were not reported.Device history record was reviewed and nothing was found related to the reported event.The 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.During tests, device reports air bubble when tube with water is installed.Calibration of the air sensor resolved the issue.This complaint will be considered as a valid, the root cause is likely due to drift of value, so air calibration needed.Please be informed that an internal capa was opened for defective air sensors, in particular a drift of the sensors.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
• MDR Report Key: 24864211
• Report Number: 3004548776-2026-00143
• Device Sequence Number: 21141923
• Product Code: FRN
• UDI-Device Identifier: 04086000851794
• UDI-Public: 04086000851794
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/13/2026
• Report Date (Section F): 04/13/2026

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/23/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2026
• 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: 04/13/2026