FDA Warns of Syringe Pumps Problems at Low Infusion Rates

September 08, 2016

The US Food and Drug Administration (FDA) issued a warning on August 25, 2016 informing health care professionals about the serious clinical consequences of programmable syringe pumps that infuse therapies at low rates, especially to infants and terminally-ill patients. A lack of continuity, according to the FDA, can result to delay of therapy, over-infusion or under-infusion.

FDA Warns of Syringe Pumps Problems at Low Infusion Rates

The FDA has published a Safety Communication notice for programmable syringe pump manufacturers that includes precautions and recommendations to lessen low-rate infusion problems. The agency also released new language for device manufacturers to include on their list of instructions which contain warnings and considerations. The FDA also advised device makers to submit new 510(k)s for any label modifications made other than the language provided.

Programmable syringe pumps, classified as Class II devices by the FDA, delivers a wide array of fluids, medications, or blood products to patients.

From March 1, 2013 to July 20, 2016, the FDA received more than 300 Medical Device Report (MDRs) regarding over and under infusion, and other mechanical malfunctions of programmable syringe pump. A third 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 healthcare providers to carefully consider syringe sizes, model selection, and use manufacturer-identified compatible components such as tubing and filters in order to mitigate potential infusion risks.

The lack of flow continuity may encompass all programmable syringe pumps capable of delivering at low infusion rates. However, the FDA is not able to determine the underlying cause of the issue due to limited information provided by MDRs, presence of patient comorbidities, and the varying syringe sizes used with the devices.

Aside from MDR data evaluation, the FDA also did a literature review and conducted MedSun surveys at hospitals on various clinical practices associated to the device and the risks they create.

AIV, Inc. is committed to providing first rate IV pumps, replacement parts, accessories and repair service for major infusion equipment manufacturers. Learn more about AIV’s wide selection of IV pump solutions at http://aiv-inc.com/iv-pump-parts-service.html.

About the Author

Laura Collier

Laura Collier

Laura Collier has a Bachelor’s Degree in Communications and a Master’s Degree in Business Administration from the University of North Florida. She is the Marketing Manager at AIV, Inc.

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