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Sigma Spectrum Infusion Pumps with Master Drug Library by Baxter Healthcare: Class I Recall - System Error May Interrupt or Delay Therapy
Includes Model No. 35700BAX and 35700ABB
AUDIENCE: Risk Manager, Biomedical Engineer, Nursing
ISSUE: Baxter has received over 3500 reports of System Error 322 “Link Switch Error (low)” incidents in which the device has malfunctioned, including nine severe adverse events and no deaths. The System Error 322 occurs when the pump improperly detects that the door is open when it is physically closed. A System Error 322 may lead to an interruption or delay in therapy.
If the System 322 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 product may cause serious adverse health consequences, including death.
BACKGROUND: Affected products were manufactured from July 1, 2005 through January 15, 2014 and distributed from February 20, 2013 through January 15, 2014.
RECOMMENDATION: Customers who encounter a System Error 322 are instructed to:
- Turn the pump off 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 need to reprogram the infusion after the pump is turned back on. If the alarm cannot be cleared using the above 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 Corporation. Baxter Healthcare can be contacted at 1-800-356-3454 (choose option 1) Monday through Friday, 7 am to 7 pm, Eastern Time.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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