The U.S. Food and Drug Administration (FDA) recently designated a Baxter Healthcare Corporation recall of Sigma Spectrum Infusion Pumps a Class I recall, its most serious designation. Class I recalls involve situations in which there exists a reasonable probability that use of the recalled products will cause serious adverse health consequences or death.
Baxter Healthcare issued a recall for its Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB. The recall was implemented due to a system error that may interrupt or delay therapy. The recalled Sigma Spectrum Infusion Pumps were manufactured from July 1, 2005 through January 15, 2014. The medical devices were distributed from February 20, 2013 through January 15, 2014.
The Sigma Spectrum Infusion Pumps with Master Drug Library are meant to deliver controlled amounts of intravenous fluids, such as medicines, blood, blood products, and other mixtures needed by patients. Administration takes place through a vein or an artery, under the skin, and into the spine, as well as other routes deemed acceptable by medical professionals. The Sigma Spectrum Infusion Pumps with Master Drug Library are used in hospitals, outpatient care facilities, and home care situations, to name a few.
To date, Baxter Healthcare has received over 3500 reports of System Error 322 “Link Switch Error (low)” incidents in which the device has malfunctioned. The reports include nine severe adverse events; no deaths have been reported.
System Error 322 occurs when the pump improperly detects that the device door is open when it is, in fact, physically closed. This type of system error may lead to an interruption or delay in therapy.
Should the System 322 error occur, the Sigma Spectrum infusion pump stops the infusion, an alarm sounds, and a light flashes with a visual “322” alarm. This error mandates that a clinician reset the alarm, re-program the pump, and confirm that the infusion is running properly.
Baxter Healthcare Corporation sent an “Urgent Device Correction” letter in February, as well as a Customer Reply Form, to all customers. The letter identified the product, the problem, and the actions to be taken. The letter also requested that customers complete the Customer Reply Form and return it by faxing the completed letter to 1.224.270.5457 or e-mailing a scanned copy to firstname.lastname@example.org.
Customers who encountered a System Error 322 were instructed to turn the pump off by pressing the ON/OFF Key and then turn the pump back on by pressing the ON/OFF key to clear the alarm. The clinician must then re-program the infusion after the pump is turned back on. Should the alarm not clear, the device should be removed from use and sent to the facility’s biomedical engineering department. If the System Error 322 re-occurs, the pump may need to be inspected and serviced by Baxter Healthcare Corporation, which may be reached toll-free, at 1.800.356.3454 (choose option 1), Monday through Friday, 7:00 a.m. to 7:00 p.m., Eastern Time.