Eitan Medical Ltd Recalls Sapphire Infusion Pumps for Failure to Detect Air in the Line

FDA Recall info.

The Sapphire infusion pumps deliver fluids, nutrition, including lipids, as well as medication, blood, and blood products such as platelets and plasma. The pumps are designed  to be used in hospitals, clinics, at home, or they may be portable.  The pumps run under both battery power and when connected to a power source.

Eitan Medical Ltd is recalling the Sapphire MT Infusion Pump, Sapphire Epidural Infusion Pump, and Sapphire Plus Infusion Pump due to software issues in software version Rev 16.10. Pumps with this software version may fail to detect air in the line when running on battery power. In some cases, the pump may not sound an alarm when there is air in the line.

Failure to detect air in the line can lead to blockage in a blood vessel (embolism), causing complications such as unstable blood pressure, stroke, heart attack, or even death.

For more information visit:  https://www.fda.gov/medical-devices/medical-device-recalls/eitan-medical-ltd-recalls-sapphire-infusion-pumps-failure-detect-air-line?utm_medium=email&utm_source=govdelivery