MAUDE Adverse Event Report: FRESENIUS KABI USA, LLC IVENIX INFUSION SYSTEM; INFUSION SAFETY MANAGEMENT SOFTWARE

Model Number	030-0028-08
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Bcma order sent to the lvp was rejected during integration testing medication via integration using dose 0.001mg/100ml - but can be manually programmed on pump.Lvp serial number: unknown.A review of the device logs indicates the following: a bcma (barcode medication administration) order with a dose of 0.001, which is the minimum dose allowed, is rejected by the pump.The lvp should reject anything under 0.001 not including 0.001.The order can still be manually programmed.Reporting due to the referenced technical issue as a conservative measure; no adverse effects or serious injuries were reported.More information is needed to complete the investigation.
Event or Problem Description
The lvp rejects orders that are not within restricted limits.In the scenario where an order is sent to the lvp with a dose or drug amount (drug amount / diluent amount makes up the concentration) that is exactly 0.001 the lvp is rejecting the order.This should be the minimum allowed value but is being evaluated as being outside of the limits.The user can proceed by manually programming the order on the lvp.

• Brand Name: IVENIX INFUSION SYSTEM
• Common Device Name: INFUSION SAFETY MANAGEMENT SOFTWARE
• Manufacturer (Section D): FRESENIUS KABI USA, LLC; 50 high street; suite 50; north andover MA 01845
• Manufacturer (Section G): FRESENIUS KABI USA, LLC; 50 high street; suite 50; north andover MA 01845
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047-8930 ; 8475502913
• MDR Report Key: 23330566
• Report Number: 3014732157-2025-01142
• Device Sequence Number: 9909571
• Product Code: PHC
• UDI-Device Identifier: 00811505030467
• UDI-Public: 00811505030467
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K183311
• 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,Followup
• Report Date (Section B): 12/05/2025

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: Other
• Device Model Number: 030-0028-08
• Device Catalogue Number: LVP-SW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown