Ivenix Infusion System 030-0028-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00811505030467), received between Apr 21, 2025 and Aug 13, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50243574 ↗
• MalfunctionFeb 18, 2026Computer Software Problem; No Apparent Adverse Event

  DUE TO A SOFTWARE DEFECT, THERE WAS A COMMUNICATION FAILURE BETWEEN THE APPLICATION AND FLOW PROCESSORS THAT RESULTED IN A FAIL STOP ALARM. THE LVP WILL ENTER A FAIL STOP ALARM AND WILL NEED TO BE POWER-CYCLED TO CONTINUE USE. WHILE IT HAS NOT BEEN REPRODUCED, THE DEFECT IN THE CODE HAS BEEN IDENTIFIED AND AN INTERNAL INVESTIGATION HAS BEEN CREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379963 ↗
• MalfunctionFeb 9, 2026Computer Software Problem; No Apparent Adverse Event

  A COHERENCE FAILURE OCCURRED DUE TO AIR IN CASSETTE BEING DETECTED AT THE EXACT TIME THAT BACKPRIME STARTED. THE PUMP DID NOT FUNCTION AS INTENDED SINCE IT ENTERED A CONTINUOUS BACKPRIME STATE WHEN THE USER STARTED THE INFUSION. BACKPRIMING SHOULD HAVE STOPPED WHEN THE BACKPRIME ALERT WAS REMOVED FROM THE SCREEN. THIS WAS REPRODUCED DURING INVESTIGATION BY MODIFYING THE CODE TO SIMULATE WHAT WAS SEEN IN THE LOGS. ATTEMPTING TO REPRODUCE THE SCENARIO MANUALLY FAILED TO REPRODUCE THE SAME RESULT AFTER SEVERAL HOURS OF ATTEMPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298847 ↗
• MalfunctionDec 1, 2025Computer Software Problem; No Apparent Adverse Event; Computer Software Problem; No Apparent Adverse Event

  FRESENIUS KABI LVP NUMERIC INPUT SCREENS USE SHARED CODE TO ENFORCE PRECISION AND VALUE LIMITS FOR PARAMETERS, WITH DIFFERENT NUMERIC POLICIES GOVERNING RANGES OF VALUES. WHEN INPUT VALUES EXCEED THE ALLOWED SIGNIFICANT DIGITS, THE CODE ATTEMPTS TO TRUNCATE DECIMALS (EVEN IF NONE EXIST) LEADING TO INCORRECT FORMATTING. THIS FLAW CAUSES THE SYSTEM TO GENERATE VALUES WITH EXCESSIVE DECIMAL PLACES, VIOLATING THE PERMITTED DECIMAL LENGTH AND TRIGGERING UNCAUGHT EXCEPTIONS THAT CRASH THE PROGRAM. THE ISSUE IS ILLUSTRATED WITH EXAMPLES WHERE INPUT STRINGS LIKE "0020" AND "00060" ARE MISHANDLED DUE TO FAULTY ASSUMPTIONS IN THE TRUNCATION LOGIC. THE ROOT CAUSE IS THE CODE'S ASSUMPTION THAT EXCESS SIGNIFICANT DIGITS ALWAYS IMPLY A DECIMAL COMPONENT THAT CAN BE TRUNCATED, WHICH IS NOT ALWAYS TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687013 ↗
• MalfunctionOct 17, 2025No Apparent Adverse Event; No Apparent Adverse Event

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330566 ↗
• MalfunctionJul 30, 2025No Apparent Adverse Event; No Apparent Adverse Event

  RN WAS SETTING UP AN INFUSION WHEN THE PUMP BEGAN ALARMING, THE TOUCH SCREEN WAS FROZEN AND WAS NOT RESPONSIVE. TOOK MULTIPLE ATTEMPTS TO FORCE A HARD SHUTDOWN. LVP SERIAL NUMBER: (B)(6). A REVIEW OF THE DEVICE LOGS INDICATES THAT THE CLINICAL APPLICATION USER INTERFACE FROZE DURING INFUSION PROGRAMMING DUE TO SOFTWARE DEFECT. LVP ENTERED FAIL STOP ALARM STATE. REPORTING DUE TO THE REFERENCED TECHNICAL ISSUE; NO ADVERSE EFFECTS OR SERIOUS INJURIES WERE REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22661822 ↗
• MalfunctionApr 21, 2025No Apparent Adverse Event; No Apparent Adverse Event

  DURING INTERNAL TESTING AT FRESENIUS KABI WITH ONE SOAKER PUMP, THE UI FROZE AND LOGS CONTAINED A REPEATED NETWORK ERROR MESSAGE. THIS OCCURRED AFTER DAS PERFORMED IT MAINTENANCE (INCL. BUT NOT LIMITED TO REBOOTING DNS SERVERS). THESE ARE THE ONLY TWO DATA POINTS FOR ASCERTAINING THE ROOT CAUSE OF THE FREEZE. REPRODUCTION HAS NOT BEEN POSSIBLE SO FAR. ATTEMPTS AT REPRODUCTION THUS FAR INCLUDE: * RERUNNING THE SQUISH TEST ORIGINALLY RUNNING ON THE AFFECTED PUMP FOR MANY DAYS * CREATING A WIFI NETWORK TO RECREATE DHCP LEASE LIMITATIONS FOUND ON IVX-LVP * CREATING A WIFI NETWORK TO REDIRECT DNS, MIMICKING DAS MAINTENANCE THE BEHAVIOR WHICH PROMPTED THE CREATION OF THIS COMPLAINT HAS NOT BEEN REPRODUCED DESPITE NUMEROUS ATTEMPTS, AND IT HAS NOT MANIFESTED OTHERWISE SINCE FIRST OBSERVATION. THE ROOT CAUSE OF THIS CANNOT BE DETERMINED BECAUSE REPRODUCTION HAS PROVEN INFEASIBLE. IF THIS BEHAVIOR OCCURRED IN THE FIELD THE CLINICIANS ABILITY TO MANAGE INFUSIONS WOULD BE IMPACTED DUE TO THE USER INTERFACE FREEZING. REPORTING DUE TO THE REFERENCED TECHNICAL ISSUE; NO ADVERSE EFFECTS OR SERIOUS INJURIES WERE REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876545 ↗

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-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-0848-2026 · Nov 3, 2025 · Open, Classified
  Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
• Z-0378-2026 · Sep 3, 2025 · Open, Classified
  Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
• 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-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-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.