Baxter Healthcare recalled more than 500,000 infusion pumps, following thousands of complaints suggesting the tubing may corrode, increasing the risk of an infusion delay or interruption in treatment.
The FDA announced the Baxter Sigma Spectrum Infusion Pump recall on December 1, indicating the manufacturer received at least 17,493 reports of the devices accumulating fluid residue or corroding, including at least 16 serious injuries. The action has been categorized as a class I medical device recall, meaning continued use may cause serious injuries or death.
The recalled infusion pumps are used in the hospital or healthcare settings to deliver controlled amounts of fluids, such as pharmaceutical drugs, blood, and blood products through tubing into a patient’s vein or other cleared routes of administration.
According to the recall announcement, due to cleaning problems, the tubing may begin to accumulate fluid residue or become corroded which could cause a blockage or delay in critical fluid delivery.
Officials warn healthcare professionals that, in the event the corrosion or fluid buildup occurs while the device is being used on battery power, the pump could unexpectedly shut down without signaling an alarm, causing a delay or complete interruption in treatment.
The recall includes Baxter SIGMA Spectrum Infusion Pump with Master Drug Library with product codes 35700ABB and 35700BAX, Baxter SIGMA Spectrum Infusion Pump with Master Drug Library with product code 35700BAX2 and Spectrum IQ Infusion System with Dose IQ Safety Software with product code 357009.
The devices were manufactured by Baxter International Healthcare Company of Deerfield, Illinois. They were distributed to hospitals and healthcare facilities nationwide from July 1, 2008 to July 14, 2020. Officials indicate approximately 553,443 units were sold throughout the U.S.
Baxter Healthcare sent an Urgent Device Correction to all known customers on August 28, with instructions on how to properly clean the infusion pumps, and to inspect all inventory to check the electrical pins on the pump rear case and the battery electrical contacts for residue buildup or corrosion. The manufacturer further instructed customers to contact Baxter for service if residue build-up is discovered.
Healthcare professionals are being instructed to keep the devices plugged in to AC power when possible to prevent battery depletion and to make sure a backup device is readily available when infusing critical medications that could cause serious injury or death if interrupted.
Customers with additional questions or concerns regarding the recall are encouraged to contact Baxter Technical Assistance at 800-356-3454. Any adverse reactions or quality problems while using the devices should be submitted through the FDA Safety Information and Adverse Event Reporting Program.