MAUDE Adverse Event Report: FRESENIUS KABI DEUTSCHLAND GMBH VOLUMAT LINE; PUMP, INFUSION

Model Number	VL PN 02-1
Medical Device Problem Codes	Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported by the customer: writer primed line and hung bag of tpn with no issues.Writer was then alerted around 1900 that tpn was leaking from the pump." writer went to inspect and found that tubing was indeed leaking from pump (at the green end of the rubber tip that goes into the pump).Writer removed tpn and hung d10 as per policy.No adverse events reported.More information is needed to complete the investigation.

• Brand Name: VOLUMAT LINE
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): FRESENIUS KABI DEUTSCHLAND GMBH; 5 robert-koch-strasse; bad hersfeld, hessen 36521 ; GM 36521
• MDR Report Key: 24601469
• Report Number: 3004548776-2026-00108
• Device Sequence Number: 8384391
• Product Code: FRN
• UDI-Device Identifier: 04250273714371
• UDI-Public: 04250273714371
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/14/2026
• Report Date (Section F): 03/14/2026

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: Health Professional
• Device Model Number: VL PN 02-1
• Device Catalogue Number: M46442460
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/13/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2026
• 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: 03/14/2026