The Food and Drug Administration (FDA) has announced a recall of specific Baxter Healthcare software-controlled infusion pumps.
Baxter Healthcare is recalling the Baxter Healthcare Sigma Spectrum Infusion Pumps with Master Drug Library (V6, V8) and the Baxter Spectrum IQ Infusion Systems with Dose IQ Safety Software (V9) because improper cleaning of the devices may lead to residue build-up or corrosion on the device. If the device is running only on battery power, this may lead to an unplanned shutdown without alarming or alerting the user. This may cause an infusion delay or an interruption in treatment. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The Baxter Healthcare Sigma Spectrum Infusion pumps with Master Drug Library (V6, V8) and the Baxter Spectrum IQ Infusion with Dose IQ Safety Software (V9) are software-controlled infusion pumps that deliver controlled amounts of fluids such as pharmaceutical drugs, blood, and blood products and other required patient therapies. The fluids are provided through an infusion tubing set into a patient’s vein or through other cleared routes of administration.
To date, there have been 17,493 complaints about this device issue and 16 reports of serious injuries. There have been no reported deaths.
Food and Drug Administration (FDA). Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues [news release]. December 1, 2020. Available at: click here. Accessed December 1, 2020.