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	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported by customer: error 37 - can't operate pump customer sent in the request form reporting: error 37 - can't operate pump.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.Device history log was reviewed.Several technical errors 37 related to the reported event were found.The reported device was received in lake zurich and its investigation was performed by our local technical team.According to provided information, the reported event was not reproduced but external inspection found delaminated start/ ok button that could firmed the reported event.During tests, ocs test failed (missing ribbon cable z179413).Internal inspection found that ribbon cable from cpu board to power supply board is missing likely due to a mishandling of the device.This complaint regarding the error 37 is considered as valid, linked to an ageing of the keypad.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: 25408798
• Report Number: 3000240707-2026-00217
• Device Sequence Number: 10669065
• Product Code: FRN
• UDI-Device Identifier: 04086000851794
• UDI-Public: 04086000851794
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/05/2026

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: 05/14/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2025
• 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