FDA issues Class I safety alert on malfunctioning infusion pumps

The U.S. Food and Drug Administration (FDA) is following up on a letter from Smiths Medical alerting customers to the potential for certain infusion pumps to trigger an erroneous alarm, interrupting the flow of medications and fluids to patients.

Due to the inherent risk associated with the disruption of an active infusion—which could be fatal in a worst-case scenario—the FDA has designated this notice as a Class I recall, the most serious type. However, no serious injuries or fatalities have been reported.

The malfunction occurs under specific conditions, causing CADD-Solis infusion pumps to trigger an upstream occlusion alarm even when no blockage is present. The issue tends to arise when there is a delay of more than one hour between priming and infusion. Because this is a critical alarm, it effectively locks down the pump.

Of note, the problem does not occur every time there is a delay between priming and infusion. After an investigation, Smiths Medical identified the following additional conditions that tend to trigger the alarm:

• The upstream occlusion alarm is enabled
• The operator is using a CADD administration set with the pump instead of a medication cassette reservoir
• “Keep Vein Open” or “Continuous Rate” modes are not programmed

While the FDA refers to this as a recall, Smiths Medical has issued updated usage instructions for the pumps, which are intended to ensure safe operation. These infusion pumps are used in both hospital and outpatient settings, depending on the model. Multiple lots are subject to the recall.