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	07/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported by customer: the air sensor failed during pre testing / inspection.Reporting as a conservative measure.Adverse effects were not reported.Device history record was not reviewed as the device has already gone through its first preventive maintenance.The device log was reviewed, no error or issue linked to the reported event was found.The device was received in lake zurich for preventive maintenance during which our local technical team found the failure of the air sensor.According to provided information, nothing was noticed during both external and internal check.The test 14 (air sensor) failed.The air sensor has been replaced to solved the issues.The problem of defective air sensors is a known topic.An investigation is underway through an internal capa in order to find all possible root causes and correct them.When the sample will be received, it will be made available to the technical team to increase the test samples if necessary.Therefore this complaint is considered as valid and the root cause is linked to a defective air sensor.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: 50117610
• Report Number: 50117610
• Device Sequence Number: 13352388
• Product Code: FRN
• UDI-Device Identifier: 04086000851794
• UDI-Public: 04086000851794
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Type of Report: Initial
• Report Date (Section B): 08/03/2026
• Report Date (Section F): 08/03/2026

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/10/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2026
• 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: 08/03/2026