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	Localized Skin Lesion (4542)
Date of Event	09/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: unit does not power on customer sent in the attached request form reporting unit not power on.Reporting as a conservative measure.No adverse event effects were reported.The device was repaired by the customer; fresenius kabi is communicating the investigation and repair results here.Fresenius kabi will not be receiving the device or the parts back for investigation as this device was manufactured greater than 3 years ago (manufacturing date: may 2015), preventative maintenance (pm) is expected to have been performed as per the device's approved maintenance schedule.Therefore, the device would have undergone two quality verifications of each essential performance parameter (at release and first pm), indicating the likelihood of a manufacturing-related issue is remote.Review of the device history record (dhr) has been deemed not required in accordance with internal procedure.Device history log was reviewed.Several technical errors (37 and 38) 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, external inspection confirmed that on/off key didn't work.So, the device could not be switched on.The root cause is linked to an ageing keypad (the device is more than 10 years old).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: 50919129
• Report Number: 3004548776-2026-00407
• Device Sequence Number: 5776597
• Product Code: FRN
• UDI-Device Identifier: 04086000851794
• UDI-Public: 04086000851794
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2026
• 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: 09/28/2026