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.
- 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:
- 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.
Reason for Recall
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.
Use of the affected product may cause serious adverse events, including death. There have been 17,493 complaints about this device issue and 16 reports of serious injuries. There have been no reported deaths.