NOVUM IQ Large Volume Pump - Important Safety Updates

Date

08/07/2025

Product

NOVUM IQ LVP

Category and References

Urgent Medical Device Correction

• Customer letter 1
• Health Canada Recall Alert RA-77905

Issue Description and Risks

Software anomalies that may result in a blank Run screen.

A blank Run screen on the NOVUM IQ LVP will not interrupt the ongoing therapy, which will continue to run to completion, but the user will not be able to adjust the ongoing therapy.

Potential Clinical Impact

An interruption of therapy will be required should the user need to adjust therapy settings. Excessive or insufficient therapeutic effects may occur in the interim period while either the pump door is opened or closed while the infusion is running, the pump is power cycled, or the pump is replaced.

Remediation

Baxter is developing a software update to resolve the issue and will contact customers once the software update is available.
In the meantime, healthcare providers may continue to use the NOVUM IQ LVPs while following the instructions below:

1. Users should rely on their clinical judgment. When providing patient care involving high risk medications and/or critical illness, users should consider utilizing an alternate pump, if available and appropriate for the patient’s treatment.

2. If an alternate pump is not available or appropriate for patient care involving high risk medications and/or critical illness, you may continue to use the NOVUM IQ LVP consistent with the following actions:

• If a blank Run screen is displayed during an infusion on the NOVUM IQ LVP, the user should open the door, press the tubing into load point 3, then load point 4, to turn the light green (pictured in Figure 1 of the letter), and close the door. If these actions do not resolve the blank screen, users should power-cycle the pump, select “Yes” to the new patient prompt, and reprogram the infusion.

Date

07/17/2025 and 02/03/2026

Product

NOVUM IQ LVP

Category and References

Urgent Medical Device Correction

• Customer letter 1
• Customer letter 2
• Health Canada Recall Alert RA-77756

Issue Description and Risks

Baxter is issuing an Urgent Medical Device Correction for the NOVUM IQ large volume pump (LVP) due to the following two issues:

1. There is a potential for underinfusion when transitioning from a lower to a higher flow rate (e.g., rate change or bolus). Specifically, the risk occurs when the second flow rate is more than double the first flow rate. For example, an increase from a 30 mL/hr primary infusion over 12 hours to a 600 mL/hr flow rate for a bolus infusion. The level of underinfusion is variable and is based on the lower infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer duration the pump has been running at the lower infusion rate and the larger the magnitude of the rate change, the larger the underinfusion would be. In the worst case, no delivery may occur.
2. Baxter has identified an increase in customer reports of over and underinfusion that may be 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.

Potential Clinical Impact

With respect to the first issue (flow rate change), this may lead to the pump delivering at a lower rate than intended (underinfusion). With respect to the second issue (set misloading), this may lead to non-delivery, underinfusion, or overinfusion of the intended solution/medication.

Remediation

Baxter is working to identify software and/or hardware corrections to address the issues and will contact customers with additional information when available.

In the meantime, healthcare providers may continue to use the NOVUM IQ LVPs while following the instructions below:

1. Users should rely on their clinical judgment. When the delay associated with changing the pump and infusion set would NOT prove detrimental to the patient, users should change out the pump and infusion set prior to initiating a bolus infusion or a rate change of greater than 100%.
2. If the delay associated with changing the pump and/or infusion set would prove unacceptable, prior to initiating a bolus infusion or a rate change of greater than 100%, users should move the administration set downstream (towards the patient) approximately 1.3 cm (0.5 inches) by following steps A through C below.
   • A. Please follow the instructions for unloading the set in section 4.4, Unloading an Administration Set, of the NOVUM IQ LVP Operator’s Manual (refer to enclosed Attachment A).
   • To prevent free flow, ensure downstream roller clamp is fully closed.
   • B. Once unloaded, move the administration set downstream by moving the slide clamp toward the container by 1.3 cm (0.5 inches).
   • C. After moving the slide clamp, reload the administration set. Please follow the instructions for loading the set in section 4.3, Loading an Administration Set, of the NOVUM IQ LVP Operator’s Manual and the additional diagrams and guidance in the enclosed Attachment A.
   • Once the tubing has been loaded, the door closed and the slide clamp has been ejected, ensure that the downstream roller clamp is fully open.
   • D. Initiate replacement of the administration set at the first safe opportunity to do so, or check regularly to ensure the infusion proceeds at the expected rate.
3. To prevent misloading, consistent with the instructions for use, customers should ensure that:
   • A. The door is fully open before loading the set as pictured on page 5 of enclosed Attachment A.
   • B. The tubing is taut and loaded without slack in the pumping channel as pictured on page 8 of enclosed Attachment A.

Please follow the instructions for loading the set in section 4.3, Loading an Administration Set, of the NOVUM IQ LVP Operator’s Manual and the additional diagrams and guidance in the enclosed Attachment A.

Update 03 February 2026:
A hardware update is now available to reduce the potential for set misloads by installing spacers around the pumping channel. One of the spacers also contains labeling highlighting key operational steps to load the set. A Baxter representative will contact your facility to schedule implementation of this update.

Date

04/29/2025

Product

NOVUM IQ LVP

Category and References

Urgent Medical Device Correction

• Customer letter 1
• Health Canada Recall Alert RA-77454

Issue Description and Risks

There is potential for underinfusion following use of the “standby mode” feature, or if the device is powered off with the administration set loaded for an extended period of time. Testing has identified that at flow rates above 50 mL/hour, certain infusions may experience flow rate variability of more than 10% when started after 2 hours and 30 minutes in standby mode or with pump powered off.

Potential Clinical Impact

If the pump infuses at a lower rate than intended, in most cases, minor or temporary harm may occur. In the high-risk populations, serious and critical adverse health consequences may occur, depending on factors such as the patient condition and medication being infused.

Remediation

Baxter is developing a software update and accompanying labeling updates to resolve the issue and will contact customers once the software update is available.
In the meantime, healthcare providers may continue to use the NOVUM IQ LVPs while following the instructions below:

1. For flow rates greater than 50 mL/hour, do not exceed a programmed standby time of 2 hours and 30 minutes. Monitor patients frequently to ensure that the appropriate infusion is being delivered.
2. Please remove the set upon powering off the device.
3. An informational poster was provided for their facility.

Date

09/15/2022 and 02/06/2023 and 12/20/2023

Product

NOVUM IQ LVP

Category and References

Urgent Medical Device Safety Alert

and

Urgent Medical Device Correction

• Customer Letter 1
• Customer Letter 2
• Customer Letter 3
• Health Canada Recall Alert
  RA-64580

Issue Description and Risks

Over-infusion at flow rates below 0.5 mL/hr for the general population, and at flow rates below 1 mL/hr with neonates when using 2R administration sets.

Potential Clinical Impact

This issue may lead to the hazardous situation of overinfusion at flow rates less than 0.5 mL/hr for general population, and less than 1 mL/hr for neonates when using 2R administration sets.  

Remediation

1. When the correction becomes available, a local Baxter representative will contact your facility. Your facility will be receiving this correction from Baxter at no charge. Baxter will work with your facility to ensure the safe and timely correction of all devices.
   
   
2. Prior to the correction, the following Risk Mitigations should be implemented: 

• For the general population, use a flow rate ≥ 0.5 mL/hr for all administration sets
• For use of 2R administration sets with neonates, use a flow rate ≥ 1 mL/hr
• Consider use of an alternative pump (e.g. syringe pump) for flow rates outside these conditions

If you need to use the NOVUM IQ LVP at a flow rate outside of the limitations described above then, ensure the IV administration set changes occur at 24-hour intervals.

Immediately discontinue use of the incompatible set (product code 1W5000) with the NOVUM IQ LVP. Contact a Baxter Clinical Representative, or Baxter Medical Information at 1-855-584-1368 or [email protected] to discuss an alternate compatible set option.