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Medical Devices / Postmarket Safety

FDA Asks Manufacturers of Syringe Pumps to Revise Labels, Warnings

Aug. 30, 2016

Manufacturers of syringe pumps are being asked to update their labels to address flow continuity concerns that the FDA has identified as a serious risk to health.

The agency issued an Aug. 25 safety notice warning that programmable syringe pumps used to infuse therapies at low infusion rates can result in serious consequences such as 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 a lack of flow continuity.

The agency is asking manufacturers to voluntarily update their labeling to include warnings and precautions to clarify the use of the devices at low infusion rates. The notice said the FDA is working with manufacturers to ensure the appropriate information is conveyed. — Tamra Sami

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