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Baxter Sigma Spectrum Infusion Pump Recall

Baxter Sigma Spectrum Infusion Pump Recall

Baxter Healthcare Corporation has issued a Class I recall for the Sigma Spectrum Infusion Pump after receiving thousands of reports of a malfunction that could cause the pump to stop working. At least nine serious incidents have been reported, but fortunately no deaths.

What You Can Do & How an Infusion Pump Lawsuit Can Help

The Schmidt Firm, PLLC is currently accepting infusion pump induced injury cases in all 50 states. If you or somebody you know was injured by the Baxter Sigma Spectrum infusion pump, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Recall Issued for Sigma Spectrum Infusion Pump

May 2, 2014 — Recall Alert After receiving 3,500 reports of a System Error 322 malfunction, Baxter has recalled the Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB.

The recalled infusion pumps were distributed between February 20, 2013 and January 15, 2014. Baxter initiated the recall in February. The U.S. Food and Drug Administration (FDA) has designated the action a Class I recall, the most serious type.

Overview

The Baxter Sigma Spectrum Infusion Pump is a medical device designed to deliver a continuous and controlled amount of liquid — medicine, blood, blood products, and other mixtures that a patient needs. The device may be used in a hospital or at home. Fluids are delivered intravenously (IV) through a vein, artery, under the skin, in the spine, or other areas of the body.

Reason for Recall

The problem is that the pump may stop working when it improperly detects that a door is open when it is actually closed. This produces a System Error 322 “Link Switch Error (low),” which interrupts the infusion, produces an alarm, and turns on a flashing light (visual “322” alarm).

What Should I Do?

If you encounter a System 322 error while using the Sigma Spectrum infusion pump, you will need to turn the system off and on again to clear the alarm. Turn the pump off by pressing the ON/OFF key, and then press it again to turn the system on. You will then need to re-program the infusion and confirm it is running properly. If the alarm does not clear, the pump should not be used. It the error happens again, the pump may need to be inspected and repaired by Baxter.

Do I have a Sigma Spectrum Infusion Pump Lawsuit?

The Schmidt Firm, PLLC is currently accepting infusion pump induced injury cases in all 50 states. If you or somebody you know was injured by the Baxter Sigma Spectrum infusion pump, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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