FDA Syringe Pump Safety Communication

Friday, October 21, 2016 10:15:00 AM

On August 25, the FDA issued a safety communication addressing problems with syringe pumps (link below). Specifically, the issue revolves around medications being delivered at low to very low flow rates (less than 5ml per hour, some less than 0.5ml per hour).  At these rates the flow can become inconsistent, resulting in clinical consequences due to over- and under-dosing.  This is particularly concerning because neonates are the most common patient population affected. 

 

There is no one brand or model of pump implicated. The FDA recommends strategies to help decrease the potential for adverse effects related to flow inconsistency.  Some of these include (1) ensuring syringe size and brand is compatible with the pumps being used, (2) using the smallest syringe possible to deliver the medication, (3) using compatible tubing and other components, and other strategies for administration (priming and purging, height of pump relative to patient). 

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm518049.htm