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Medical Devices / Submissions and Approvals

FDA Issues Warning for Infusion Pumps, Fluid Warmers and Rapid Infusers

Feb. 4, 2019

The FDA released potential risks for intravascular air-in-line and air embolism events associated with rapid infusers, fluid warmers and infusion pumps.

The agency said that false air-in-line alarms can occur when air is not present or when the amount of air detected is so small that it would not pose a risk to the patient. When the alarm goes off, infusion is forcibly stopped, which could cause delays or therapy interruptions.

From January 2016 through December 2018, three percent of MDRs for the devices described air-in-line events. A small number of reports cited error messages that caused therapy delays during critical medication infusion, as well as potential air embolisms and patient deaths.

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