of chemotherapy drugs
Credit: Bill Branson
Baxter Healthcare Corporation is recalling some of its infusion pumps after receiving more than 3500 reports of the pumps malfunctioning.
According to the US Food and Drug Administration (FDA), the malfunctioning pumps have resulted in 9 severe adverse events but no deaths.
This Class I recall includes Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB.
The pumps were made between July 1, 2005, and January 15, 2014. They were distributed between February 20, 2013, and January 15, 2014.
The Sigma Spectrum infusion pumps are intended to deliver controlled amounts of medicines, blood, blood products, and other intravenous fluids.
The FDA said there have been more than 3500 reports of these pumps malfunctioning—specifically, reports of System Error 322 “Link Switch Error (low).” This error occurs when the pump detects that the door is open even though it is closed. A System Error 322 may lead to an interruption or delay in therapy.
When this error occurs, the Sigma Spectrum infusion pump stops the infusion, an alarm sounds, and a light flashes (a visual “322” alarm). This requires a clinician to reset the alarm, reprogram the pump, and confirm the infusion is running properly.
The use of affected pumps may cause serious adverse health consequences, including death; hence, the Class I recall.
Customers who encounter a System Error 322 should turn off the pump by pressing the ON/OFF key, then turn the pump back on by pressing the ON/OFF key to clear the alarm.
Clinicians will need to reprogram the infusion after the pump is turned back on. If the alarm cannot be cleared using these instructions, the device should be removed from use and sent to the facility’s biomedical engineering department.
If the System Error 322 reoccurs, the pump may need to be inspected and serviced by Baxter Healthcare. To contact Baxter, call 1-800-356-3454 (choose option 1) Monday through Friday, 7 am to 7 pm, Eastern Time.
Adverse reactions or quality problems related to these pumps can be reported to the FDA’s MedWatch Program.
