Ivenix Infusion System 030-0027-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811505030443), received between Oct 22, 2024 and Mar 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (2 reports).

25 other recalls cover devices cleared under the same FDA submission (K183311); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Computer Software Problem; No Apparent Adverse Event; Computer Software Problem; No Apparent Adverse Event

  THERE IS A MISMATCH BETWEEN WHAT IS SHOWN ON THE LVP AND WHAT IS SHOWN ON THE IMS DEPLOYED REPORTS FOR MODIFIER LABELS WHEN AN EXISTING MODIFIER IS UPDATED BUT IS NOT DEPLOYED. THE MANAGE MODIFIERS TOOL IS USED TO CONFIGURE MODIFIERS IN THE DRUG LIBRARY. IF THE USER DOES NOT DEPLOY MODIFIER LABELS AFTER MODIFICATION AND SELECTS TO RUN A DEPLOYED INFUSATES REPORT, THERE IS A MISMATCH BETWEEN THE LABELS SHOWN ON THE LVP AND WHAT IS SHOWN ON THE IMS DEPLOYED REPORTS. THE EXPECTATION IS THAT THESE REPORTS SHOW WHAT HAS BEEN DEPLOYED TO THE PUMP. A DEFECT RISK ASSESSMENT WAS COMPLETED AT THE END OF MARCH 2025. THE RISK HAS BEEN CATEGORIZED AS ACCEPTABLE WITH THE SEVERITY OF HARM ASSESSED AS NEGLIGIBLE (OCCURRENCE OF HARM IS IMPROBABLE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599746 ↗
• MalfunctionMar 13, 2025Computer Software Problem; No Apparent Adverse Event; Computer Software Problem; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: DURING INTERNAL TESTING, THERE IS A SCENARIO WHERE THE LVP MODIFIER MENU MAY NOT DISPLAY THE MODIFIER AS SHOWN IN THE INFUSION MANAGEMENT SYSTEM (IMS). FOR EXAMPLE, IF A MODIFIER NAME WAS CHANGED AFTER INFUSATES WERE DEPLOYED AND THEN THE USER SELECTIVELY DEPLOYS INFUSATE(S) WITHOUT SELECTING THE OPTION TO "DEPLOY ALL MODIFIERS", THERE IS A SCENARIO WHERE THE IMS AND LVP BECOME MISALIGNED FOR INFUSATES THAT WERE NOT MARKED AS UPDATED AND/OR SELECTED TO BE DEPLOYED IN THE IMS DEPLOYMENT MANAGER. FOR THOSE INFUSATES(S) THAT ARE NOT DEPLOYED, THE CHANGED MODIFIER IS NO LONGER DISPLAYED AS AN OPTION ON THE LVP. THE LVP AND IMS MODIFIER MENU ARE NOT ALIGNED WHEN THE MODIFIER IS CHANGED AFTER DEPLOYMENT IN A CERTAIN SCENARIO. THE LVP DOES NOT DISPLAY THE MODIFIER'S PROGRAMMING LIMIT AS AN OPTION IN ITS MODIFIER MENU IN THE SCENARIO WHEN IT HAS BEEN CHANGED IN IMS AND THEN THE USER DOES NOT CHOOSE TO "DEPLOY ALL MODIFIERS" AND ONLY SELECTIVELY. AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. A DEFECT RISK ASSESSMENT IS CURRENTLY BEING PERFORMED WHILE INVESTIGATING THIS ISSUE. FRESENIUS KABI IS SUBM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599745 ↗
• MalfunctionOct 22, 2024Insufficient Flow or Under Infusion; Infusion or Flow Problem; No Apparent Adverse Event; Insufficient Flow or Under Infusion; Infusion or Flow Problem; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: A MEDICATION ERROR INVOLVING VANCOMYCIN ADMINISTRATION ON THE IVENIX PUMP. THE CORRECT DOSE WAS SELECTED, BUT THE SELECTED CONCENTRATION WAS INCORRECT AND THIS RESULTED IN AN INFUSION RATE ERROR. THERE WAS NO PATIENT HARM. ADDITONAL INFORMATION: "ONLY INFUSED 150 ML OF THE 250 ML BAG. INFUSED AT 150 ML/HR INSTEAD OF 250 ML/HR." 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507453 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183311. One submission often covers many models, so check the product and lot details in each record.

• Z-2223-2026 · May 6, 2026 · Open, Classified
  LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
• Z-2224-2026 · May 6, 2026 · Open, Classified
  Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
• Z-2274-2026 · Feb 4, 2026 · Open, Classified
  The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
• Z-1048-2026 · Nov 21, 2025 · Open, Classified
  Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
• Z-0885-2026 · Nov 14, 2025 · Open, Classified
  Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
• Z-0848-2026 · Nov 3, 2025 · Open, Classified
  Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
• Z-0586-2026 · Nov 3, 2025 · Open, Classified
  IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
• Z-0378-2026 · Sep 3, 2025 · Open, Classified
  Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
• Z-2235-2025 · Jun 24, 2025 · Open, Classified
  LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
• Z-2233-2025 · Jun 24, 2025 · Open, Classified
  LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
• Z-2232-2025 · Jun 24, 2025 · Open, Classified
  LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
• Z-2234-2025 · Jun 24, 2025 · Open, Classified
  LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
• Z-1869-2025 · May 12, 2025 · Open, Classified
  IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
• Z-1019-2025 · Jan 10, 2025 · Open, Classified
  Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through cli
• Z-0763-2025 · Dec 6, 2024 · Open, Classified
  Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

…and 10 more.