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# FDA Cautions on Syringe Pump Flow Problems
- URL: https://www.fdaweb.com/fda-cautions-on-syringe-pump-flow-problems/
- Published: 2016-08-25T12:00:00.000Z
- Updated: 2026-09-14T21:27:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136611

In a safety communication to healthcare professionals, FDA [says](http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm518049.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) that when using programmable syringe pumps to infuse therapies at low rates (less than 5 mL per hour and especially less than 0.5 mL per hour), an inconsistent rate of delivery can result in serious clinical consequences, including delay of therapy, over-infusion, and under-infusion. “Reports of serious adverse events such as abnormal or unstable blood pressure, anxiety from loss of sedation, and increased pain indicators in critically ill infants have been associated with lack of flow continuity,” the notice says. “FDA believes that these concerns may extend to all programmable syringe pumps while infusing at low rates. Based on current information, FDA believes that the overall benefits of programmable syringe pumps outweigh their risks. Moving forward, FDA has requested that manufacturers make labeling changes to their pumps to address flow continuity concerns.”

The notice includes a full explanation of the issue, FDA’s review of information, and recommended steps for healthcare professionals to follow.