Novum IQ 40700BAXUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,192 adverse event reports that list this exact device (DI 05413765851797), received between Aug 27, 2024 and Sep 22, 2026 — classified as 4 deaths, 119 injuries, 1,069 malfunctions.

The most frequently reported specific device problem is “Filling Problem” (336 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K211122); 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.

Recalls naming this device

1. Aug 4, 2025Class IOpen, Classified

   Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

   Z-2332-2025 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

2. Jul 14, 2025Class IOpen, Classified

   Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.

   Z-2173-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,192 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Filling Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50854186 ↗
• MalfunctionSep 22, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849376 ↗
• MalfunctionSep 21, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849271 ↗
• MalfunctionSep 18, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50821442 ↗
• MalfunctionSep 16, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792350 ↗
• MalfunctionSep 16, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787220 ↗
• MalfunctionSep 8, 2026False Alarm; Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50678768 ↗
• MalfunctionAug 28, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50505987 ↗
• MalfunctionAug 18, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50307776 ↗
• MalfunctionAug 11, 2026Filling Problem

  It was reported that a Novum IQ Large Volume Pump infused at a different rate than programed. This was observed in the biomedical service department. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50214569 ↗
• MalfunctionAug 11, 2026No Display/Image

  It was reported that a Novum IQ Large Volume Pump turned on; however, there was no display output. This was observed in the biomedical service department. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50214188 ↗
• MalfunctionJul 29, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50074818 ↗
• MalfunctionJul 7, 2026Excess Flow or Over-Infusion; Protective Measures Problem

  IT WAS REPORTED THAT A NOVUM IQ LARGE VOLUME PUMP RAN AT HIGHER RATE THAN PROGRAMMED (OVER-INFUSION). THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP IN THE EMERGENCY ROOM. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONALLY, A SYSTEM ERROR (SE) 20602 (MONITOR MOTOR STALL) WAS IDENTIFIED DURING DEVICE EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25732959 ↗
• MalfunctionJun 19, 2026False Alarm

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NOVUM IQ LARGE VOLUME INFUSION PUMPS HAD DOWNSTREAM OCCLUSION ALARMS AT RATES ABOVE 899 ML/HR. THIS OCCURRED WHILE THE DEVICES WERE BEING USED WITH BAXTER SETS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566509 ↗
• MalfunctionJun 19, 2026Filling Problem

  IT WAS REPORTED THAT A NOVUM IQ LARGE VOLUME PUMP OVERINFUSED DURING INFUSION. MAGNESIUM IV WAS INITIATED ON PATIENT; WHEN THE NURSE RETURNED ROUGHLY 10 MINUTES LATER ENTIRE BAG HAD INFUSED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563758 ↗
• MalfunctionJun 18, 2026Filling Problem

  IT WAS REPORTED THAT A NOVUM IQ LARGE VOLUME PUMP UNDERINFUSED DURING INFUSION. THE PUMP HAD MEROPENEM PROGRAMMED IN TO RUN OVER 3 HOURS. INFUSION AND FLUSH COMPLETED ROUGHLY 3.5H AFTER INITIATION AND REGISTERED NURSE NOTED THAT MEDICATION BAG STILL HAD ROUGHLY HALF THE VOLUME REMAINING. THE REMAINDER OF MEDICATION ADMINISTERED AND NEXT DOSE PUSHED FORWARD 2 HOURS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552603 ↗
• MalfunctionJun 18, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT A NOVUM IQ LARGE VOLUME PUMP WAS PROGRAMMED TO DELIVER A UNIT OF PACKED RED BLOOD CELLS (PRBCS) AT 120ML/HR DURING PATIENT INFUSION; HOWEVER, THE PUMP DID NOT INFUSE WITHIN THE FOUR HOUR TIME LIMIT FOR BLOOD ADMINISTRATION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549838 ↗
• MalfunctionJun 18, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT A NOVUM IQ LARGE VOLUME PUMP HAD LOW FLOW/LOW VOLUME. THIS WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549582 ↗
• MalfunctionJun 17, 2026Failure to Sense

  IT WAS REPORTED THAT A NOVUM IQ LARGE VOLUME PUMP EXPERIENCED A DOWNSTREAM OCCLUSION DESCRIBED AS ¿LOW OCCLUSION¿. THIS ISSUE OCCURRED DURING AN UNSPECIFIED PROCESS STEP, AND IT WAS UNKNOWN IF A PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25541884 ↗
• MalfunctionJun 17, 2026Failure to Sense

  IT WAS REPORTED THAT A NOVUM IQ LARGE VOLUME PUMP EXPERIENCED AN UNDEFINED OCCLUSION DESCRIBED AS ¿OCCLUSION OUT OF RANGE¿. THIS ISSUE OCCURRED DURING AN UNSPECIFIED PROCESS STEP, AND IT WAS UNKNOWN IF A PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25541876 ↗
• MalfunctionJun 17, 2026Filling Problem

  IT WAS REPORTED THAT A NOVUM IQ LARGE VOLUME PUMP HAD "LOW FLOW/LOW VOLUME" DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25538449 ↗
• MalfunctionJun 17, 2026Failure to Sense

  IT WAS REPORTED THAT A NOVUM IQ LARGE VOLUME PUMP DID NOT ALARM WHEN AN OCCLUSION WAS PRESENT. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25538267 ↗
• MalfunctionJun 17, 2026Filling Problem

  IT WAS REPORTED THAT A NOVUM IQ LARGE VOLUME PUMP HAD ¿LOW FLOW/LOW VOLUME¿ DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25538264 ↗
• MalfunctionJun 17, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT A NOVUM IQ LARGE VOLUME PUMP HAD LOW FLOW/VOLUME. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537601 ↗
• MalfunctionJun 16, 2026Filling Problem

  IT WAS REPORTED THAT A NOVUM IQ LARGE VOLUME PUMP EXPERIENCED AN UNDERINFUSION ISSUE DESCRIBED AS ¿LOW FLOW/LOW VOLUME¿. THIS ISSUE OCCURRED UNSPECIFIED PROCESS STEP AND IT WAS UNKNOWN IF A PATIENT WAS CONNECTED FOR THERAPY AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25526687 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211122. One submission often covers many models, so check the product and lot details in each record.

• Z-1767-2025 · Apr 24, 2025 · Open, Classified
  Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS