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

Model Number	VL SP40-11
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	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: when we hook a secondary line lot 32261475 to the primary lot 32213335 its not pulling at all, it's the like the port for the primary isn't being pushed all the way in to let the secondary drip.No adverse event reported.1.Reported complaint - malfunction area unknown.2.Quantity of sample(s) - we did not receive any sample or picture for investigation.3.Concerned product code / batch.Infusion set vl sp40-11, (m46445475), 32213335.4.Investigation report: due to the fact that there was no samples or pictures provided we are not able to confirm if the failure is related to the production process or material fault.Based on the reason for the complaint, we 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, we performed a free flow and tightness test on one sample and found no abnormalities.Additionally, we conducted a practical test with water, combining the sample with infusion set vl00-xp, butch number 32261475.During the tests, there was no free flow issue or any leakage.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: we 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 07.01.2025 to 06.01.2026) we have received 1 complaint for this article with the same reason as "malfunction area unknown".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 we 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
• 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: 24031783
• Report Number: 9681819-2026-00003
• Device Sequence Number: 16070424
• Product Code: FRN
• UDI-Device Identifier: 04250273733884
• UDI-Public: 04250273733884
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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 Model Number: VL SP40-11
• Device Catalogue Number: M46445475
• Device Lot Number: 32213335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2025
• 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