After receiving over 3,500 reports of malfunctions, Baxter has issued a Class I recall of the Sigma Spectrum Infusion Pump. Nine serious adverse events have been reported, but fortunately no deaths.
Need a Texas Infusion Pump Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by the Sigma Spectrum infusion pump, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
Baxter Sigma Spectrum Infusion Pump Recall
May 2, 2014 — Baxter Healthcare Corporation has issued a recall notification for the Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB. Products were sold from February 20, 2013 through January 15, 2014. The recall was classified as the most serious Class I type.
What is the Sigma Infusion Pump?
Sigma Spectrum Infusion Pumps are used to deliver controlled amounts of intravenous (IV) fluids, including medicine, blood, blood products, and other mixtures as required for each patient. These fluids are administered through a vein or artery, under the skin, into the spine, and more.
What is the problem?
Thousands of malfunctions have occurred when the pump improperly detected that the door was open when it was physically closed, which will interrupt the infusion and require a clinician to reset the alarm, reprogram the pump, and confirm that the infusion is running properly.
The malfunction produces a System Error 322 “Link Switch Error (low).” When this occurs, the infusion stops, an alarm sounds, and a light flashes (a visual “322” alarm).
Customers who encounter a System 322 error should turn off the pump by pressing the ON/OFF key, then turn the pump back on by pressing the ON/OFF key in order to clear the alarm. Clinicians will then need to reprogram the infusion after the pump is turned back on.
If the alarm cannot be cleared, the pump should be removed from use and sent to the biomedical engineering department. If the error reoccurs, the pump may need to be inspected and serviced by Baxter.
Need an Infusion Pump Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas infusion pump lawyers for a free lawsuit review.