Dive Brief:
- Baxter has recalled its Novum IQ large volume pump in response to an under-infusion risk linked to one serious injury report, the Food and Drug Administration said Friday.
- Baxter is keeping the pumps on the market and updating the instructions to advise users on how to prevent the devices from infusing up to 50% less than the set amount. More than 34,500 units are affected across the U.S. and Canada, according to a recall database entry.
- Variability of 10% or more can put infants at risk of dehydration, inadequate drug therapy and nutrition and insufficient blood infusion, the FDA said, leading to serious harm and death.
Dive Insight:
Physicians use the Baxter Novum IQ Syringe Pump to provide intravenous infusions of parenteral fluids, blood and blood products to patients. Baxter wrote to customers about a problem with the devices in April.
There is a risk of under-infusion after the “standby mode” feature is used or if the device is powered off with the set loaded. The administration set can compress when left loaded in the pump for an extended period, causing under-infusion when the device is used.
Baxter found the risk increases when infusing at higher flow rates after longer duration in standby mode or powered off. The company advised users against using a programmed standby time of 2.5 hours or longer when delivering flow rates of greater than 50 mL/hour. Variability of more than 10% can happen under those conditions.
The company saw variability of 50% in its worst-case scenario. Baxter used a maximum flow rate of 1200 mL/hour and maximum standby time of 12 hours as its worst-case scenario. Variability is lower under other, more typical conditions but the FDA said under-infusing by 10% can harm infants.
Baxter asked users to monitor patients frequently to ensure the appropriate infusion is being delivered and to remove the set when they turn the pump off. The company provided a poster for customers to keep with their pumps.
The recall affects a growing part of Baxter’s business. Heather Knight, chief operating officer at Baxter, said on an earnings call in May that the U.S. infusion system business achieved double-digit sales growth in the first quarter as the rollout of the Novum IQ pump platform continued.
“The backlog and pipeline on Novum is strong. We have taken market share in the low single-digit range already,” Knight said.
Many pumps in the market are more than a decade old, the COO said, “so we’re bringing new technology to the market with smarter, more sophisticated capabilities on interoperability with digital suites that are going to follow to supplement that launch.”
