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

Model Number	VL SL00-XP
Medical Device Problem Codes	Break (1069); Connection Problem (2900); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported a safety concern regarding the secondary infusion set.This was a near miss and noticed prior to hanging on the patient, but the tip of the secondary infusion set spike broke off and was floating in the antibiotic.

• 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: 25210601
• Report Number: 9681819-2026-00023
• Device Sequence Number: 16054688
• Product Code: FRN
• UDI-Device Identifier: 04250273733884
• UDI-Public: 04250273733884
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/18/2026

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 SL00-XP
• Device Catalogue Number: M77460052
• Device Lot Number: 32024446
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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