Baxter International has voluntarily paused shipments and planned installations of its Novum infusion pump.
In April, the FDA reported an underinfusion risk with the company’s Novum IQ large-volume pump after “standby mode.” In mid-July, the FDA said doubling the flow rate can also result in underinfusion.
The degree of underinfusion can “range from minor or temporary harm to severe harm, depending on the patient, the condition being treated and the fluid, drug or other treatment being administered,” according to the FDA.
During a July 31 earnings call with investors, Baxter executives said the shipment pause is temporary, adding that the company’s goal is to resume shipments and installations this year.
Baxter has reported 79 serious injuries and two deaths associated with this issue.
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