Baxter’s recall of the system involves updating instructions for use. It does not require removal from use or sale. However, the FDA identified it as the most serious type of recall, carrying the risk of injury or death. The issue affects all Novum IQ large-volume pumps, which the FDA cleared last year.
On April 24, Baxter sent all affected customers a letter after becoming aware of the potential for underinfusion with the pump. This may occur following the use of “standby mode,” or if the device is powered off with the set loaded. According to the FDA’s notice, keeping the administration set loaded in the pump for an extended period of time may result in an underinfusion on the subsequent infusion due to compression of the set. Risk increases when infusing at higher flow rates after a longer duration in standby mode or powered off.
Baxter said testing identified that certain infusions may experience flow rate variability at rates above 50 mL/hour. That variability can rise above 10% after two hours and 30 minutes. In the worst-case scenario, Baxter reports the potential for 50% underinfusion at the maximum flow rate of 1,200 mL/hour and the maximum standby time of 12 hours.
At 10% variability, Baxter says pediatric patients may face the risk of dehydration and inadequate drug therapy and nutrition. They may also face insufficient blood infusion, leading to increased risk of morbidity and mortality.
To date, Baxter reports one serious injury and no deaths associated with the issue.
The company instructed customers not to exceed a programmed standby time of two hours and 30 minutes. They should also monitor patients frequently and remove the set upon powering off the device.
