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News From the Food and Drug Administration
October 4, 2016

Programmable Syringe Pump Alert

JAMA. 2016;316(13):1350. doi:10.1001/jama.2016.13805

An FDA safety alert has warned that infusing therapies with programmable syringe pumps at low rates—less than 5 mL per hour and especially less than 0.5 mL per hour—can result in an inconsistent delivery rate that may cause serious complications.

From March 2013 to July 2016, the FDA received more than 300 medical device reports linking the pumps with overinfused and underinfused high-risk or life-sustaining medication, occlusion detection failures, inadvertent boluses resulting from inconsistent fluid delivery, and other mechanical malfunctions that delayed therapy. Among 100 device reports that noted the infusion rates, the majority were 5 mL an hour or less (http://bit.ly/2bSVkHz).

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