CareFusion Alaris PC Unit, Model 8015: Class I Recall - Error Code

AUDIENCE: Risk Manager, Critical Care Medicine

ISSUE: FDA notified healthcare professionals of a Class I Recall of the Alaris PC unit, model 8015. A component on the PC unit power supply board is causing an error code (120.4630): "System Error" or "Missing Battery Error" to occur. The error code is accompanied by both an audible alarm and a visual error message on the PC unit screen. If the error code occurs at start-up, the Alaris infusion pump cannot be programmed and this may cause a delay in patient therapy. If the error code occurs during infusion, the health care provider cannot make programming changes to current infusions, and this may result in serious injury and/or death to the patient.

BACKGROUND: The Alaris PC unit, model 8015 is part of the Alaris electronic infusion pump. Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.

RECOMMENDATION: On June 27, 2012, CareFusion sent an Urgent Medical Device Recall Notice to customers who purchased the Alaris PC unit, model 8015. CareFusion will contact customers by phone within 60 days of receiving the letter to schedule a visit to replace the affected power supply board on the PC unit.

• If the error messages are observed, remove the PC unit from use and contact the CareFusion Recall Support Center at 1-888-562-6018.
• For clinical areas administering high-risk infusions, consider having additional devices as back-up until affected devices are remediated.

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 Class I Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm314090.htm