Cardinal Healthcare

Alaris Pump Module System

Alaris EtCO2 Module Model 8300 Frequently Asked Questions Guide Dec 2015

Guide

3 Pages

December 7, 2015  Alaris® EtCO2 Module (Model 8300) Frequently Asked Questions (FAQ’s) – For External Use The following FAQs are for external use regarding the customer letter delivered on December 7, 2015  1.  What device is affected? Alaris EtCO2 Module Model 8300 that were repaired in CareFusion’s Service Department from March 3, 2015 through April 28, 2015.  2.  What is the issue? CareFusion has identified a short time period where EtCO2 modules were tested during service using a higher than specified concentration of CO2. An incorrect blood gas mixture with a CO2 concentration of 7% was used to calibrate and verify EtCO2 Modules in the Repair Center. The correct blood gas mixture should have had a CO2 concentration of 5%. If undetected during check-in, the Point of Care Unit connected to the EtCO2 module will display a waveform of lower amplitude than normal.  3.  What actions is CareFusion taking? CareFusion will contact all affected facilities by mail to notify them of this recall.  4.  How do I return affected device(s) to a CareFusion facility for remediation? − − − − − − −  5.  Customer with the affected serial numbers shall call the CareFusion Support Center (CSC) at 888-562-6018. CSC will receive a list of the affected serial numbers from the customers for return. CSC will create a Return Good Authorization for each serial number. CSC will send boxes and CareFusion paid shipping labels. Customer will pack and label the devices with the boxes and labels provided by CareFusion and send to a CareFusion facility. CareFusion will perform remediation activities. CareFusion will send the devices back to the customer with updated documentation.  Who pays the shipping for affected devices sent to the CareFusion facility? CareFusion pays all of the shipping costs.  6.  Who should I contact if I have additional questions about this recall? Please contact the CareFusion Recall Support Center directly at 888-562-6018.  © 2015 CareFusion Corporation or one of its subsidiaries. All rights reserved. Alaris, CareFusion and the CareFusion logo are trademarks or registered trademarks of CareFusion Corporation or one of its subsidiaries.  Page 1
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