The FDA informed health care professionals on August 25, 2016, 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. While lack of flow continuity can occur with other types of infusion pumps, this issue is particularly relevant to programmable syringe pumps that infuse therapies at low rates. Programmable syringe pumps can provide accurate delivery of fluids and medications over a wide range of infusion rates, including rates less than 5 mL per hour. In general, the lower the infusion rate, the higher the potential for problems to occur when certain techniques and/or accessory devices are used.
Programmable syringe pumps deliver solutions such as fluids, medications, or blood products to patients. They are capable of delivering at low infusion rates in increments as small as tenths or hundredths of a milliliter per hour, and programming capabilities can include intermittent, fixed-volume, constant-rate infusions, and, particularly with critically-ill patients, continuous infusions subject to frequent adjustment or titration, as needed. They are commonly used in settings where patients may need highly concentrated medication doses because of fluid restriction or fluid intolerance, such as neonatal intensive care units. Accessory devices used with programmable syringe pumps include a syringe that holds the solution, and infusion tubing that connects the syringe to the patient through intravenous or enteral access.
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 and is not specific to any manufacturer or model of device. 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 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.
The FDA recommends that health care professionals consider the following information when using programmable syringe pumps to help reduce the potential for serious adverse events. Ensure syringe sizes and models are compatible with the syringe pump (refer to the manufacturer’s instructions for use). Use of incompatible syringes can cause improper pump operation resulting in inaccurate fluid delivery, insufficient occlusion (blockage) sensing, and other potential problems. Use the smallest compatible syringe size necessary to deliver the fluid or medication; this is especially important when infusing high risk or life-sustaining medications at low infusion rates (e.g., less than 5 mL per hour, and especially flow rates less than 0.5 mL per hour). This is due to the increased friction and variable compliance of the syringe plunger tip with larger syringes.
Use manufacturer-identified compatible components such as tubing which have the smallest internal volume or “deadspace” to minimize residual volumes between the syringe and the patient when administering medications or fluids at low infusion rates. This reduces the amount of time it takes for fluid to reach the patient, maintains delivery accuracy, and reduces occlusion detection times.
See the FDA Safety Alert
See the FDA Recall
See also Medical Law Perspectives June 2014 Report: Physician and Manufacturer Risks for Pain Pump Injuries: Malpractice, Negligence, and Products Liability
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication