Baxter Novum IQ Pump Underinfusion and Overinfusion Risk
Baxter Novum IQ Large Volume Pumps may infuse medication at incorrect rates during flow-rate transitions or due to improper tubing loading. The 36,705 affected units worldwide should be checked per safety instructions.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification for medical devices affecting drug delivery requires a minimum severity score of 4. No illnesses or injuries are reported in the source text, precluding a Critical score.
Plain-English summary
Baxter Healthcare Corporation is recalling the Novum IQ Large Volume Pump (Product Code REF 40700BAXUS) due to potential infusion rate errors. The recall affects 36,705 units distributed worldwide, including the United States and Canada.
The pump may deliver medication at lower or higher rates than programmed under two conditions: when increasing the flow rate by more than double (such as during a rate change or bolus), or when the infusion set tubing is not properly loaded into the pump channel. Underinfusion severity depends on how long the pump has been running at the initial flow rate and the magnitude of the rate increase. Proper set loading is critical; the tubing must be taut and loaded without slack in the pumping channel.
Healthcare facilities and users should immediately verify proper setup by ensuring the door is fully open before loading the set and that tubing is positioned correctly without slack. Baxter recommends reviewing the instructions for use to prevent dosing errors.
This is a Class I recall issued by the U.S. Food and Drug Administration.
The recalled product
- Product
- Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- underinfusion
- overinfusion
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 05413765851797
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
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