Class I Recall: Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library
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, reported the U.S. Food and Drug Administration (FDA).
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 because use of these devices may cause serious injuries or death.
There have been 17,493 complaints about this device issue and 16 reports of serious injuries. There have been no reported deaths.
Recalled products include:
· Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
Product Code: 35700ABB and 35700BAX
· Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
Product Code: 35700BAX2
· Spectrum IQ Infusion System with Dose IQ Safety Software
Product Code: 357009
Manufacturing dates include:
· Product code - 35700BAX and 35700ABB (Version 6): 01/01/2005 - 05/13/2020
· Product code - 35700BAX2 (Version 8): 07/01/2014-Present
· Product code - 3570009- (Version 9): 04/12/2018-Present
Distribution Dates: July 1, 2008 to July 14, 2020
Devices Recalled in the U.S.: 553,443
Date Initiated by Firm: April 1, 2020
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. The devices are used in hospitals and other healthcare facilities.
