Recall Class: Class I
Date Recall Initiated: February 7, 2014
Products: Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB
Affected products were manufactured from July 1, 2005 through January 15, 2014 and distributed from February 20, 2013 through January 15, 2014.
Use: Sigma Spectrum Infusion Pumps with Master Drug Library are intended to deliver controlled amounts of intravenous fluids including medicines, blood, blood products and other mixtures required by patients. The routes of administration include a vein or an artery, under the skin, into the spine, and other acceptable routes. The Sigma Spectrum Infusion Pumps with Master Drug Library are used in, but not limited to, hospitals, outpatient care, and home care.
Baxter Healthcare Corporation
1 Baxter Parkway
Deerfield, Illinois 60015-4625
Reason for Recall:
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.
- Patients: Contact your doctor or home care agency.
- Affected customers should contact Baxter Healthcare at 1-800-356-3454 (choose option 1) Monday through Friday, 7 am to 7 pm, Eastern Time.
FDA District: New York District Office
More Information about this Recall:
On February 7, 2014, Baxter Healthcare Corporation sent an “Urgent Device Correction” letter and a Customer Reply Form to all customers. The letter identified the product, problem, and the actions to be taken.
Baxter asked customers to complete the Customer Reply Form and return it to them either by faxing 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, 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.
About Class I Recalls:
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.