Alaris CareFusion Pump
August 27, 2012
FDA is informing healthcare providers of two Class I recalls of CareFusion’s Alaris Pump, model 8100. The first is due to loose door keypad overlays that may peel away or become completely separated from the door assembly. The loose door keypad overlay could result in fluid leaks leading to improper keypad function leading to infusion cessation. This could result in patient harm or death. Affected units were distributed from October 1, 2011 to February 31, 2012. A list of affected serial numbers can be found at the following link: http://www.carefusion.com/pdf/Alerts_and_Notices/Alaris/Alaris_LVP_model_8100_delamination_serial_number_list_ver01.pdf CareFusion alerted customers of the recall by letter on June 27, 2012 and asked them to inspect their device for overlay separation. The company will contact customers by phone to schedule a time to replace affected doors.
The second recall is due to motor stops during infusion mainly with high infusion rates (>900 mL/hr). The unit and pump display an error code (242.4030) with an alarm and cessation of the infusion. This could result in patient harm or death. Affected units were distributed from October 1, 2011 to February 31, 2012. CareFusion alerted customers of the recall by letter on July 20, 2012. If the motor stalls on a unit, do not use the device and contact the CareFusion Support Center. Facilities administering high-risk infusions should consider having alternative devices available until the issue is resolved. A list of affected serial numbers can be found at the following link: http://www.carefusion.com/pdf/Alerts_and_Notices/Alaris/Alaris_LVP_8100_motor_stall_serial_number_list_ver01.pdf
Contact the CareFusion Support Center at 1-888-562-6018 with any inquiries regarding the recall and CareFusion Customer Advocacy at 1-800-854-7128 for adverse event reports.
Additional information is available at the following links:
MedWatch Safety Alert:
FDA Recall Notice:
CareFusion Recall Letter:
August 27, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.