Syringe Pump Flow Issues at Slow Infusion Rates
August 25, 2016
FDA received more than 300 medical device reports related to the use of programmable syringe pumps from March 2013 to July 2016. These reports described several issues potentially due to inconsistent flow including accidental boluses, occlusion detection failures, and over or under infusion. One-hundred of these reports included information on infusion rates and the majority of these stated the issue(s) occurred at rates of 5 mL/hr or slower. The inconsistent flow may have contributed to adverse events including complications from loss of sedation, increased pain markers in critically ill infants, and unstable blood pressure.
FDA believes the issue exists for all programmable syringe pumps and is not unique to any one pump manufacturer or model. The issue seems to be present at infusion rates 5 mL/hr or slower, and particularly at rates less than 0.5 mL/hr. FDA is requesting that manufacturers of programmable syringe pumps update their product labeling to describe the concerns with inconsistent flow at slow infusion rates. The benefits of these programmable syringe pumps still seem to outweigh their risks when used properly. To reduce the risk of adverse events related to syringe pump use, FDA recommends using syringe sizes and models that the pump manufacturer states are compatible with the pump, and using the smallest compatible size of syringe. Other general pump safety recommendations are described in the FDA Safety Communication and FDA Infusion Pump Risk Reduction Strategies linked below.
More information is available at the following links:
- FDA MedWatch Alert:
- FDA Safety Communication:
- FDA Infusion Pump Risk Reduction Strategies:
August 25, 2016; University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.