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	06/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported by customer: customer reports that this is a newly unboxed unit that they tested and it throws them error code 49 while performing the pm.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 history was not provided therefore no review could be performed.The reported device was not returned to lake zurich nor brézins for investigation.According to local protocol, if after 20 days the device still hasn't been returned, the service order is closed to no device.So, we did not receive anything that would allow us to identify the actual root cause of this event / to go further with this investigation.Therefore the root cause of the reported issue could not be identified.However, if further information are provided later on we may re-open the complaint and pursue its.To our knowledge this complaint is not being related to patient safety this complaint is considered as: not investigated 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: 25667981
• Report Number: 3004548776-2026-00280
• Device Sequence Number: 14852154
• Product Code: FRN
• UDI-Device Identifier: 04086000851794
• UDI-Public: 04086000851794
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/30/2026
• Report Date (Section F): 06/30/2026

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: 06/04/2026
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2026
• 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: 06/30/2026