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

Model Number	VL PR 44-12
Medical Device Problem Codes	Obstruction of Flow (2423); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported by the customer: pt was being treated with folfiri, treatment had been initiated, approx 29 ml of irinotecan had infused.Lines being used were a primary set (non-pump line, referred to as rescue line") directly connected to patient's port gripper connector) a volumat line (primary pump line non-filtered) connected to the lowest port of the "rescue line" and a second volumat line connected to lowest port of 1st volumat line.Both pump lines were in pumps and in use.Volumat line 1 was pumped as programmed but 2nd volumat pump was alarming "distal occlusion".Upon investigation it was found that the lowest port of the 1st volumat line was obstructed/not functioning.This was confirmed by connecting a 10 ml ns syringe and attempting to flush through when no longer connected to patient.There would have been approx.20 ml of irinotecan in the line that was discarded along with the volumat line that had malfunctioned." 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
• Manufacturer (Section G): FRESENIUS KABI DEUTSCHLAND GMBH; 5 robert-koch-strasse; bad hersfeld, hessen 36521 ; GM 36521
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047
• MDR Report Key: 24646571
• Report Number: 9681819-2026-00008
• Device Sequence Number: 21311893
• Product Code: FRN
• UDI-Device Identifier: 04250273731965
• UDI-Public: 04250273731965
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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 PR 44-12
• Device Catalogue Number: M46445780
• Device Lot Number: 32395425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown