FDA warns on programmable syringe pumps

The FDA today released a safety communication warning of problems with lack of flow continuity when programmable syringe pumps are set to low flow rates.

The federal watchdog released the safety notice for any practitioners who would operate or work with programable syringe pumps and those who administer high risk and life-sustaining medication therapies.

Programmable syringe pumps are designed to deliver solutions such as fluids, medications and blood products to patients, and are capable of doing so in very small doses and low infusion rates. The devices are commonly used for patients who need highly concentrated medication doses due to issues such as fluid restriction or fluid intolerance.

The agency warned of the possibility of the devices developing a lack of flow continuity when set at low flow rates of less than 0.5 mL per hour. Lack of flow continuity can result in consequences such as delay of therapy, over-infusion and under-infusion.

The FDA said it has received 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. Over 300 medical device reports have been filed with the FDA between March 1, 2013 and July 20 this year which describe over and under-infusion events.

The federal watchdog did not name any particular programmable syringe pumps in its warning, and listed a number of steps to be taken to reduce or eliminate the risk of lack of flow continuity.

Among the list of steps the FDA recommended were selecting accessory components with the smallest internal volume, manually priming the syringe and tubing, placing the syringe pump level with the distal tip of the catheter and taking extra considerations to recognize occlusions.

Despite the issues, the FDA said it still believes the overall benefit of the devices outweigh the risks, and the agency requested that the manufacturers make labeling changes to the syringe pumps to “address flow continuity concerns.”

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