Sapphire (infusion pumps)

2023: Recall of pumps causing stroke

On December 1, 2023, the U.S. Food and Drug Administration (FDA) announced the recall of Eitan Medical infusion pumps, which are used worldwide. The use of defective equipment can cause serious harm to the health of patients and even provoke death.

The defect was found in Sapphire Multi-Therapy, Sapphire Epic and Sapphire Plus pumps. These devices are designed to introduce various fluids, nutrients, as well as drugs, blood and blood products into the body. The devices are suitable for use in clinical settings and at home. They can be powered by a mains or battery.

Eitan Medical's Sapphire Pumps

The recall affects the listed infusion pumps software since Rev 16.10. Due to firmware errors, devices may not detect air in the line when running on battery power. In some cases, no audible alarms are raised. The FDA notice says that having air in the line can lead to blockages in blood vessels (embolism), causing complications and side effects such as unstable blood pressure, stroke and heart attack. In severe cases, the problem can lead to the death of a person receiving therapy.

The defect affects approximately 1,400 Sapphire Multi-Therapy, Sapphire Epic and Sapphire Plus devices. As of December 1, 2023, cases of harm to the health of patients or deaths due to a defect were not recorded. The manufacturer recommends that medical institutions stop using these pumps in battery mode or add a special filter to prevent air from entering the line. By the end of the first quarter of 2024, a software update will be available in which the problem will be fixed.^[1]

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