MAUDE Adverse Event Report: FRESENIUS KABI USA LLC IVENIX INFUSION SYSTEM; LARGE VOLUME PUMP (LVP) SOFTWARE

Model Number	030-0028-07
Medical Device Problem Codes	Computer Software Problem (1112); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following has been reported: pump problem when trying to program and start an infusion.Unknown if an active infusion was stopped.Reporting as a conservative measure.No adverse effects were reported.Additional information is needed to complete the investigation.
Additional Manufacturer Narrative
Sections d2a & d2b updated to alight with information listed on gudid.
Event or Problem Description
The device triggered a pump problem alarm instead of a tubing set misloaded alert.The combination of rapid unloading and reloading of an admin set, with the set misloaded in such a way that the resistor is unable to couple, can lead to the start button no longer being grayed out.Programming an infusion and pressing on the start button as the pump is trying to couple with the admin set can result in a coherence failure, triggering a pump problem alarm.The defect risk assessment determined the risk and severity to be a 1 - inconvenience.No further action is planned at this time.

• Brand Name: IVENIX INFUSION SYSTEM
• Common Device Name: LARGE VOLUME PUMP (LVP) 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 ; 8475502913
• MDR Report Key: 20623048
• Report Number: 3014732157-2024-00804
• Device Sequence Number: 8820390
• Product Code: FRN
• UDI-Device Identifier: 00811505030436
• UDI-Public: 00811505030436
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2024

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
• Device Model Number: 030-0028-07
• Device Catalogue Number: LVP-SW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 11/06/2024; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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