The correction follows reports that extended standby time or leaving the pump powered off with an administration set loaded may reduce flow delivery.
Baxter has issued a letter to affected customers recommending Novum IQ large volume pumps to be corrected prior to use due to a potential for underinfusion, according to a medical device recall notice from the US Food and Drug Administration (FDA).
The correction is recommended if the device has been powered off with the administration set loaded, or after the “standby mode” feature has been activated. Keeping the administration set loaded in the pump for an extended amount of time may result in underinfusion due to the compression of the set. The risk increases when infusing at higher flow rates after a longer duration in standby mode or powered off.
These large volume pumps are intended to provide intravenous infusion of drugs, IV nutrition, blood, and blood products. Underinfusion can lead to patient dehydration, inadequate drug therapy, and nutrition. Underinfusion in pediatric patients may create an increased risk of morbidity and mortality.
Baxter has reported one serious injury and no deaths associated with this issue.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Photo caption: Novum IQ large volume pumps
Photo credit: Baxter
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