The FDA has warned of a serious potential issue with Novum IQ large-volume infusion pumps made by Baxter (NYSE: BAX) .
Our sister site, Drug Delivery Business News, reports today that Baxter recently warned customers of the potential for underinfusion with the pump.
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’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 risk of injury or death.
Get the full story at our sister site, Drug Delivery Business News.
