FDA issues Safety Alert for programmable syringe pumps

Editor's Note

The Food and Drug Administration (FDA) on August 25 issued a Safety Alert for practitioners using programmable syringe pumps to infuse medications and solutions at low rates (eg, less than 5 mL/hour, and especially at less than 0.5 mL/hour).

The FDA has received more than 300 reports that describe over- and under-infusion of medications, occlusion (blockage) detection failures, inadvertent boluses, and other mechanical malfunctions.

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 linked to lack of flow continuity.

Based on current information, the FDA believes the overall benefits of programmable syringe pumps outweigh their risks, and the agency has asked manufacturers to make labeling changes to address flow continuity concerns.

Reports of serious clinical consequences, such as over- and under- infusion of high risk or life-sustaining medications, occlusion detection failures, inadvertent boluses caused by inconsistent fluid delivery, and other malfunctions.