MAUDE Adverse Event Report: FRESENIUS KABI DEUTSCHLAND GMBH VOLUMAT LINE; ADMINISTRATION SET, INTRAVASCULAR

Model Number	VL PR44-12
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: primary line infusing chemotherapy leaked at the distal port (port farthest from the pump).The glue appeared to look stringy and let go from the plastic end of the port.A small amount of chemotherapy leaked onto the patient's arm, chair, and floor.No adverse event was communicated.Investigation summary as follows: 1.Reported complaint leakage at needle free port 2.Quantity of the sample(s) no complaint sample available for investigation, only one photo 3.Concerned product code/batch infusion set vl pr44-12 (nam) - m46445780 / batch unknown 4.Investigation report we have not received a complaint sample for investigation.We received one photo witch shows part of our product inside the foil bag - only k-zero and tube.It was visible a drops of fluid inside the bag.Nevertheless, it is not clearly visible a place of leakage.Based on photo we did not able to confirm where the leakage occured.As we did not receive the batch number, an inspection of retained samples and review of batch documentation was not possible.Without faulty sample and batch number, a more detailed investigation was not possible.In the last 12 months (from (b)(6) 2024 to (b)(6) 2025) we have received 1 complaint for this article with the same reason as "leakage at needle free port".5.Root cause without the complaint sample and batch number root cause analysis we are not able to perform adequate root cause analyses.6.Corrective action.Corrective and preventive actions are not necessary as we are not able to perform root cause analyses 7.Conclusion based on these results we are not able to confirm this complaint.

• Brand Name: VOLUMAT LINE
• Common Device Name: ADMINISTRATION SET, INTRAVASCULAR
• Manufacturer (Section D): FRESENIUS KABI DEUTSCHLAND GMBH; 5 robert-koch-strasse; bad hersfeld, hessen 36521 ; GM 36521
• MDR Report Key: 23751493
• Report Number: 3004548776-2025-00622
• Device Sequence Number: 21189239
• Product Code: FPA
• UDI-Device Identifier: 04250273731965
• UDI-Public: 04250273731965
• 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): 12/08/2025
• Report Date (Section F): 12/08/2025

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 PR44-12
• Device Catalogue Number: M46445780
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/27/2025
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2025
• 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: 12/08/2025