AUDIENCE: Nursing, Pediatrics, Pharmacy, Critical Care Medicine
ISSUE: 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., inconsistent rate of delivery) can result in serious clinical consequences, including delay of therapy, over-infusion or under-infusion.
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 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.
BACKGROUND: 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.
RECOMMENDATION: Health professionals should refer to the specific recommendations in the FDA Safety Communication when using programmable syringe pumps. For additional information, see the FDA web page Infusion Pump Risk Reduction Strategies.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
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Complete and submit the report Online:
www.fda.gov/MedWatch/report
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA safety communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm518074.htm
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