According to the FDA’s safety communication alert, 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., inconsistent rate of delivery) can result in serious clinical consequences, including delay of therapy, over-infusion or under-infusion.”
There have been reports of serious adverse events that the FDA believes may extend to all programmable syringe pumps that infuse at low rates, such as:
- Unstable or abnormal blood pressure
- Anxiety from loss of sedation
- Lack of flow continuity that leads to increased pain indicators in critically-ill infants
Despite these adverse events, 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.”
This safety communication results from the following:
From March 01, 2013 to July 20, 2016, the FDA received over 300 Medical Device Reports (MDRs) associated with programmable syringe pump use. The reports describe over- and under- infusion of high risk or life-sustaining medications, occlusion (blockage) detection failures, inadvertent boluses caused by inconsistent fluid delivery, and other mechanical malfunctions that result in delays in therapy. Of the 100 MDRs that provided information on the infusion rates, the majority of those MDRs noted infusions at rates of 5 mL per hour or less, including rates as low as 0.06 mL per hour.
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Lead image photo credit: Philipp Lensing.