Novum IQ 40800BAXUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 348 adverse event reports that list this exact device (DI 05413765852428), received between Oct 5, 2023 and Sep 25, 2026 — classified as 16 injuries, 332 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (84 reports).

4 FDA recall records name this device's identifier, 4 still open.

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 11, 2026Class IIOpen, Classified

   A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

   Z-3065-2026 · Root cause: Software design · Recall details · FDA record ↗

2. 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-2333-2025 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

3. May 12, 2025Class IIOpen, Classified

   Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.

   Z-1964-2025 · Root cause: Device Design · Recall details · FDA record ↗

4. Mar 3, 2025Class IIOpen, Classified

   Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.

   Z-1423-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 348 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Connection Problem

  It was reported that an unspecified quantity of Novum IQ Syringe Pumps had connection concerns when used with 35 mL non-Baxter ENFit syringes. Similar concerns were reported with another type of non-Baxter ENFit syringe. This occurred 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 50897292 ↗
• MalfunctionSep 24, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891198 ↗
• MalfunctionSep 24, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890976 ↗
• MalfunctionSep 18, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50824227 ↗
• MalfunctionSep 7, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658554 ↗
• MalfunctionSep 1, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546052 ↗
• MalfunctionAug 26, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459555 ↗
• MalfunctionAug 14, 2026False Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50262028 ↗
• MalfunctionAug 14, 2026False Alarm; Filling Problem; Failure to Sense

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261878 ↗
• InjuryAug 11, 2026Filling Problem

  It was reported that a Novum IQ Syringe Pump underinfused continuous morphine for pain/sedation. The patient was concurrently receiving a continuous D30 fluid infusion and vecuronium through other syringe pumps. During initial setup, a 10 mL syringe was selected and dispensed. After priming, the syringe was reloaded, and the pump reportedly offered a 50 mL syringe option, which was confirmed by the user. Subsequently, multiple ¿disposable not loaded¿ messages were reportedly recorded; however, no associated syringe reload events or user re-confirmations of syringe size/type were identified for the corresponding ¿syringe loading complete¿ entries. The reporter stated that the patient became tachycardic and appeared to be awakening despite paralysis, suggesting inadequate sedation despite increasing sedation doses. No additional information is available.

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

  MAUDE report 50212916 ↗
• MalfunctionJul 30, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50092410 ↗
• MalfunctionJul 29, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50077377 ↗
• MalfunctionJul 29, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50077376 ↗
• MalfunctionJul 29, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50077352 ↗
• MalfunctionJul 28, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058743 ↗
• InjuryJul 27, 2026Backflow; Filling Problem

  It was reported that a Novum IQ Syringe Pump underinfused Fentanyl infusion and allowed IV fluids to back up into the medication syringes. The patient was receiving continuous infusions through a 4 French right internal jugular (RIJ) central line, including dextrose 5% in 0.9% sodium chloride at 18 mL/hour via large volume pump (LVP), fentanyl administered at 0.47 mL/hour, midazolam administered at 0.47 mL/hour, and precedex administered at 0.71 mL/hour. Fentanyl, midazolam and precedex were administered using three separate Novum IQ syringe pumps. During infusion verification in the electronic medical record, an error message was encountered stating, ¿Unable to calculate volume... The volume calculator has detected a potential negative rate or volume and could not suggest a calculation.¿ Staff attempted to determine the cause of the error but were unable to identify an explanation. The infusion pumps were subsequently manually cleared. Following clearance, the midazolam syringe pump displayed a negative volume value of -0.814 mL despite the infusion having run for approximately two hours. In addition, approximately three hours after initiation, the midazolam syringe reportedly sti

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

  MAUDE report 50040050 ↗
• InjuryJul 27, 2026Backflow; Filling Problem

  It was reported that a Novum IQ Syringe Pump underinfused Precedex infusion and allowed IV fluids to back up into the medication syringes. The patient was receiving continuous infusions through a 4 French right internal jugular (RIJ) central line, including dextrose 5% in 0.9% sodium chloride at 18 mL/hour via large volume pump (LVP), fentanyl administered at 0.47 mL/hour, midazolam administered at 0.47 mL/hour, and precedex administered at 0.71 mL/hour. Fentanyl, midazolam and precedex were administered using three separate Novum IQ syringe pumps. During infusion verification in the electronic medical record, an error message was encountered stating, ¿Unable to calculate volume... The volume calculator has detected a potential negative rate or volume and could not suggest a calculation.¿ Staff attempted to determine the cause of the error but were unable to identify an explanation. The infusion pumps were subsequently manually cleared. Following clearance, the midazolam syringe pump displayed a negative volume value of -0.814 mL despite the infusion having run for approximately two hours. In addition, approximately three hours after initiation, the midazolam syringe reportedly sti

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

  MAUDE report 50040049 ↗
• MalfunctionJul 9, 2026Protective Measures Problem

  DURING EVALUATION OF A RETURNED NOVUM IQ SYRINGE PUMP, THE DEVICE ALARMED SYSTEM ERROR 21502 (FLANGE SENSOR FAILURE). THIS OCCURRED DURING EVALUATION, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25763426 ↗
• MalfunctionJul 8, 2026Protective Measures Problem

  DURING EVALUATION OF A RETURNED NOVUM IQ SYRINGE PUMP, THE DEVICE ALARMED SYSTEM ERROR 21503 (OCCLUSION SENSOR RAILED FAILURE) AT START UP. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25752781 ↗
• MalfunctionJun 26, 2026Failure to Sense

  IT WAS REPORTED THAT A NOVUM IQ SYRINGE PUMP ALARMED SYSTEM ERROR 21502 (FLANGE SENSOR FAILURE) 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 25642626 ↗
• MalfunctionJun 26, 2026Protective Measures Problem

  IT WAS REPORTED THAT A NOVUM IQ SYRINGE PUMP ALARMED SYSTEM ERROR 21503 (OCCLUSION SENSOR RAILED FAILURE). THIS WAS OBSERVED DURING PROGRAMMING/SETUP IN THE BIOMED SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638602 ↗
• MalfunctionJun 19, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT A NOVUM IQ SYRINGE PUMP UNDERINFUSED DURING INFUSION. VANCOMYCIN 59 MG/11.8ML DOSE WAS INFUSED USING A 20 ML NON-BAXTER SYRINGE. THE NURSE RESPONDED TO INFUSION COMPLETE ALARM AND NOTED THERE WAS 3ML STILL REMAINING IN SYRINGE. THE PUMP SCREEN DISPLAYED 11.8 ML WAS ADMINISTERED. THE NURSE STATES THERE WAS EXACT AMOUNT IN SYRINGE WHEN INFUSION WAS PROGRAMMED/STARTED. 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 25563203 ↗
• MalfunctionJun 12, 2026Protective Measures Problem

  IT WAS REPORTED THAT A NOVUM IQ SYRINGE PUMP ALARMED SYSTEM ERROR 21503 (OCCLUSION SENSOR RAILED FAILURE). THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP IN THE BIOMED SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25490757 ↗
• MalfunctionJun 11, 2026Filling Problem

  IT WAS REPORTED THAT A NOVUM IQ SYRINGE PUMP HAD FLOW ISSUE DURING MOCK INFUSION. THE DEVICE WAS PROGRAMMED WITH A CONCENTRATION OF 20 MG/ML, A DOSE OF 2 MG, AND A PATIENT WEIGHT OF 1.2 KG; HOWEVER, A HARD LIMIT SCREEN WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25472031 ↗
• MalfunctionJun 10, 2026Backflow

  IT WAS REPORTED THAT THERE WAS BACKFLOW OF NORMAL SALINE INTO THE SYRINGE DURING USE OF A NOVUM IQ SYRINGE PUMP. THE PATIENT HAD ONE INTRAVENOUS (IV) ACCESS. A PERIPHERAL INTRAVENOUS LINE, NORMAL SALINE FLUIDS, AND THREE STOPCOCKS WERE HOOKED INTO IV HUB. FROM THE IV SITE, THE FIRST STOPCOCK WAS OPEN TO ALL SIDES AND HAD FENTANYL RUNNING ON THE SYRINGE PUMP. THE SECOND STOPCOCK WAS OPEN TO ALL SIDES AND HAD PROPOFOL RUNNING ON AN UNSPECIFIED LARGE VOLUME PUMP (LVP). THE THIRD STOPCOCK WAS CAPPED AND CLOSED TO THE EMPTY PORT. NORMAL SALINE ¿WAS RUNNING AT THE BACK AS THE MIVF/CARRIER AT 40-50 AN HOUR ON A LVP¿. PHYSICIAN ORDERED A BOLUS OF NORMAL SALINE, AND THE NORMAL SALINE LVP WAS REPROGRAMED TO 999 ML/HR TO DELIVER BOLUS. "LVP AND SYRINGE PUMP ALARMED DOWNSTREAM OCCLUSION BUT WOULD RESTART". FENTANYL SYRINGE POPPED OUT OF SYRINGE PUMP AND WHEN PLACED BACK INTO THE SYRINGE PUMP, THE PUMP ALARMED THAT THE SYRINGE HAD 55 MLS, WHICH WAS MORE THAN EXPECTED. THE NURSE REALIZED THE SYRINGE HAD 15 OR MORE MLS OF EXTRA FLUID IN THE SYRINGE. THE PATIENT¿S PAIN CONTROL WAS INTERRUPTED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462236 ↗