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

Model Number	VL PN 02-1
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported by the customer: leak at y-joint micron filter line running tpn and lipids broke\disconnected entirely, after y-site port on iv line, closest to patient.Tpn and lipids ran onto patient and bedding, leaving patient soaked.Tpn bag along with lines discarded due to risk of infection.1.Reported complaint leakage at needle free port 2.Quantity of sample(s) fresenius kabi did not receive any sample or picture for investigation 3.Concerned product code / batch infusion set vl pn 02-1 (usa), (m46442460), 32232375 4.Investigation report due to the fact that there was no samples or pictures provided, fresenius kabi is not able to confirm if the failure is related to the production process or material fault.Based on the reason for the complaint, fresenius kabi performed a visual inspection of all retain samples and do not see any defects.The sets are complete and free from contamination.In the next step, fresenius kabi performed a free flow and tightness test on one sample and the results were correct.Batch documentation review was performed and following data was checked: production orders, in process control and final inspection results, compliance with device master record, related nonconformities.Result: fresenius kabi did not find any deviations related to the complaint reason within the batch documentation.Without complaint sample more detailed investigation is not possible.In the last 12 months (from 09.04.2025 to 08.04.2026) we have received 1 complaint for this article with the same reason as "leakage at needle free port".This is the first complaint for this article, failure and batch number until now.5.Root cause not determined, as the no defects have been found during investigation performed on the retain sample, further no irregularities detected during review of production documentation.Without the affected sample is not possible to performed root cause analysis.6.Corrective action a corrective and preventive actions is not necessary as we are not able to perform root cause analysis.7.Conclusion based on these results, fresenius kabi cannot confirm this complaint.

• 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: 24958262
• Report Number: 3004548776-2026-00178
• Device Sequence Number: 10093353
• 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): 04/22/2026
• Report Date (Section F): 04/22/2026

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
• Device Lot Number: 32232375
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/24/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2026
• 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: 04/22/2026