The FDA is informing health care professionals that when using programmable syringe pumps to infuse therapies at low rates (e.g., less than 5 mL per hour, and especially at flow rates of less than 0.5 mL per hour), a lack of flow continuity (i.e., an inconsistent rate of delivery) can result in serious clinical consequences, including delayed therapy, overinfusion, or underinfusion.
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 the lack of flow continuity. The FDA believes that these concerns may extend to all programmable syringe pumps while infusing at low rates. Based on current information, the FDA believes that the overall benefits of programmable syringe pumps outweigh their risks. Moving forward, the FDA has requested that manufacturers make labeling changes to their syringe pumps to address flow-continuity concerns.
From March 1, 2013, to July 20, 2016, the FDA received more than 300 medical device reports (MDRs) associated with the use of programmable syringe pumps. The reports described overinfusion and underinfusion of high-risk or life-sustaining medications; occlusion detection failures; inadvertent boluses caused by inconsistent fluid delivery; and other mechanical malfunctions that resulted in delays in therapy. Of the 100 MDRs that provided information on infusion rates, the majority noted infusions at rates of 5 mL per hour or less, including rates as low as 0.06 mL per hour.
Source: FDA; August 25, 2016.