Infusion pumps recalled over underinfusion when flow rate more than doubles

Plain-English summary

The Baxter Novum IQ Large Volume Pump, product code REF 40700BAXUS, UDI-DI 05413765851797, is the subject of an Urgent Medical Device Correction covering all serial numbers. The action covers 36,705 units distributed in the United States and Canada.

Baxter issued the correction because of the potential for underinfusion when the pump transitions from one flow rate to a higher flow rate that is more than double the current rate, for example on a rate change or bolus. The level of underinfusion varies with the current infusion rate, how long the pump has been running at that rate, and the size of the rate change: the longer the pump has run at the current rate and the larger the change, the larger the underinfusion. Baxter has also identified an increase in customer reports of over- and underinfusion potentially caused by set misloading, where tubing that is not properly loaded into the pump channel may cause the pump to infuse above or below the programmed rate. The FDA classified the action as Class I, its most serious category.

Baxter instructs customers, consistent with the instructions for use, to ensure that the door is fully open before loading the set and that the tubing is taut and loaded without slack in the pumping channel. Hospitals operating these pumps should follow Baxter's correction notice in full.

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
• dosing-error
• set-misloading
• infusion-pump
• class-i

Affected units

36,705

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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