MAUDE Adverse Event Report: FRESENIUS KABI USA, LLC IVENIX INFUSION SYSTEM; LARGE VOLUME PUMP (LVP) SOFTWARE (ORDER 1 PER PUMP)

Model Number	030-0028-07
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reviewing the source code showed that the root cause of the problem was a timing issue that could occur if the user were to start the secondary infusion just as the primary infusion was transitioning to kvo.A fix was implemented that ensures that the primary is not set to follow if it transitions into kvo and follow up testing has confirmed that this fix was successful.This will be a part of the next sw release.
Event or Problem Description
The following has been reported: if the secondary inlet is started at the end of the final stroke of the running primary infusion the primary gets set to follow with a vtbi of 0.When the secondary completes it will switch over to the primary inlet at the programmed primary rate and continue until user stops the infusion or bag empties.A preliminary review of the logs identified the following issue: due to a software anomaly in the handling of starting a secondary infusion as the primary enters into kvo, the primary infusion can get set to follow the secondary infusion with a vtbi of 0.When the secondary completes it will switch over to the primary inlet at the programmed primary rate and continue until user stops the infusion or bag empties.Overdose potential note - this was found during internal testing of the next revision of sw yet to be released; the defect exists in the current released version of sw.An active infusion was not stoppped.Reporting as a conservative measure.No adverse effects were reported.Additional information is needed to complete the investigation.
Additional Manufacturer Narrative
N/a.

• Brand Name: IVENIX INFUSION SYSTEM
• Common Device Name: LARGE VOLUME PUMP (LVP) SOFTWARE (ORDER 1 PER PUMP)
• Manufacturer (Section D): FRESENIUS KABI USA, LLC; 50 high street; suite 50; north andover MA 01845
• Manufacturer (Section G): FRESENIUS KABI LLC; 50 high street; suite 50; north andover MA 01845
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047-8930
• MDR Report Key: 20571410
• Report Number: 3014732157-2024-00775
• Device Sequence Number: 8226737
• 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
• Report Date (Section B): 11/27/2024

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: 10/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/27/2024
• 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