FDA MedWatch - Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall - Alarm Error

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall - Alarm Error

AUDIENCE: Risk Manager, Nursing

ISSUE: CareFusion is recalling the Alaris Syringe Pump because of a faulty Air-In-Line (AIL) sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. If the AIL sensor is faulty, the false alarm may be repeated and require the health care provider to clear the alarm to restart the infusion. Interruption of infusion could lead to serious adverse health consequences or death.

• Product Numbers:  147083-102, 49000221
• Manufacturing Dates: October, 2011 to June, 2015
• Distribution Dates: October, 2011 to June, 2015
• Devices Recalled in the U.S. 349,746 units

BACKGROUND: The Alaris Syringe Pump is an infusion pump that delivers fluids, such as nutrients, blood and medications, into a patient’s body in controlled amounts. The syringe holds the solution, and the infusion tubing connects the syringe to the patient through intravenous or enteral access. The device is indicated for use in adults, pediatric patients, and infants and only used in hospitals and other health care facilities.

RECOMMENDATION: On December 2, 2016, CareFusion sent a “Medical Device Safety Notification” to affected customers. The notice instructed that if an AIL alarm occurs; the user should do the following:

1. Determine if there is air visible in the tubing that has caused the alarm to go off. If there is air visible in the line, press the “Restart” key to advance the air bubble past the sensor. Evacuate the air from the tubing according to your standard practice.
2. If no air is visible, ensure that the tubing is installed correctly in the AIL sensor. When inserting the tubing into the AIL sensor, use a fingertip and firmly push the tubing toward the back of the AIL sensor.
3. If the AIL alarms continue to reoccur on the same pump, after air has been removed from the line and the tubing has been correctly installed, the AIL sensor may be faulty. The health care provider should remove the pump from service, and notify CareFusion. If the AIL sensor needs to be replaced, CareFusion will provide replacement parts at no charge.
4. Review the AIL tip sheet that provides instructions on troubleshooting problematic AIL alarms.
5. Access the AIL video that provides instructions on troubleshooting problematic AIL alarms.

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 alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm540869.htm