FDA MedWatch - Alaris Syringe Pump by CareFusion: Class I Recall - Alarm Error May Cause Interruption of Therapy

Alaris Syringe Pump by CareFusion: Class I Recall - Alarm Error May Cause Interruption of Therapy

AUDIENCE: Risk Manager, Biomedical Engineering, Nursing

ISSUE: An error in the Alaris Syringe Pump model number 8110 triggers a visual and audible alarm and causes the pump to stop supplying the infusion to the patient. Even when the user clears the error code 351.6740, the syringe pump does not respond to key presses until the product is detached and reattached to the PC unit used to program, monitor and provide power to the syringe pump. Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death. CareFusion has received 108 reports of the issue occurring. There have been no reports of permanent injury or death.

BACKGROUND: A syringe pump is a small infusion pump that delivers fluids, such as nutrients and medications, into a patient’s body in controlled amounts. They are widely used in clinical settings such as hospitals, nursing homes, and in the home.

RECOMMENDATION: The firm informed customers of the problem in a July 20, 2015 letter and indicated the company will contact all affected customers within 60 days to schedule a repair. Until the affected units can be repaired, CareFusion recommends customers take the following actions if the 351.6740 error code occurs:

• Consider using another syringe pump.
• Use an IV syringe push if clinically appropriate.
• Clearly mark and sequester the Alaris Syringe pump that exhibited the channel error code.
• Notify CareFusion Support Center at 888-562-6018 or supportcenter@carefusion.com.

Customers should establish back-up plans, in case of an infusion pump failure, that allow clinicians to obtain a working infusion pump and infusion tubing quickly.

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
• 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 Class I Recall notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm460152.htm