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# FDA: Reduce Risks in Infusion Pumps, Warmers, Infusers
- URL: https://www.fdaweb.com/fda-reduce-risks-in-infusion-pumps-warmers-infusers/
- Published: 2019-01-31T12:00:00.000Z
- Updated: 2026-09-15T00:59:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143272

FDA is providing safety information and recommendations to help users of infusion pumps, rapid infusers, fluid warmers, and their accessory devices reduce the risk of air being introduced in a blood vessel (air-in-line) and air embolism associated with the devices. An agency [safety communication](https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm630142.htm?ref=fdaweb.com) says that while air-in-line sensors are meant to prevent or reduce the risk of air embolisms, there sometimes can be false alarms or nuisance alarms.

“From 1/2016 through 12/2018, approximately 3% of Medical Device Reports associated with infusion pumps, rapid infusers, fluid warmers, and accessory devices describe events with air-in-line issues,” the communication says. “The majority of the air-in-line issues involve malfunctions of the air-in-line alarm or error messages displayed by the device that did not cause patient injury.”

A small number of reports described error messages that may have caused delays in therapy when critical medications were infused and potential air embolisms and patient deaths, some of which were reported to be confirmed by imaging.

FDA says that air-in-line issues are not specific to any manufacturer or device model. The agency says it recommends that healthcare professionals, biomedical or clinical engineers, and patients and caregivers (for home use) plan ahead and monitor using specific recommendations in the communication.