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

Model Number	VL PR 72-11
Medical Device Problem Codes	Infusion or Flow Problem (2964); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported by the customer: a registered nurse reported that a kabi vmc agilia prim filter had a saline-filled chamber but would not bypass the chamber into the line.One bag of saline was discarded with the set.No adverse events reported.

• 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: 24293093
• Report Number: 3004548776-2026-00047
• Device Sequence Number: 15802059
• Product Code: FRN
• UDI-Device Identifier: 04250273714333
• UDI-Public: 04250273714333
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 02/09/2026
• Report Date (Section F): 02/09/2026

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 Expiration Date: 08/20/2026
• Device Model Number: VL PR 72-11
• Device Catalogue Number: M46445860
• Device Lot Number: 32341583
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/03/2026
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2026
• 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: 02/09/2026