Dear Valued Alaris™System Customer:
Director of Biomedical Engineering
Director of Nursing
Director of Risk Management
BD has identified an issue with the Alaris™ EtCO2 Module Model 8300 that is detected during device implementation. This notification is intended to provide information about the importance of testing and recommended steps for users to take.
Alaris™ EtCO2 modules model 8300 that were calibrated during production between December 13, 2017 through December 30, 2017.
Alaris™ EtCO2 modules were calibrated with an incorrect CO2 gas concentration during production between December 13, 2017 through December 30, 2017.
Device implementation testing should be performed prior to installation of the EtCO2 module as specified in the Alaris System Maintenance Manual and the Alaris System User Manual. If device implementation testing is not performed, the Alaris EtC02 may provide lower readings of CO2 (up to 20% error) during patient use. If a patient is monitored with a device providing 20% inaccurately low readings compared to real values, the inaccuracies could mislead clinicians and delay the identification of early respiratory depression. There have been no reports of serious injury or death.
Required Action for Users
Customers with the affected serial numbers should call the BD Support Center at 888-562- 6018 to schedule service of the devices at the BD Service Depot.
Follow-up Actions by BD
BD will contact all affected facilities within 60 days to initiate the return process for the
affected EtCO2 modules. BD will recalibrate the EtCO2 modules using a 5% CO2 gas
concentration and send the devices back to the customer.
The US Food and Drug Administration has been notified of this action. Any adverse reactions
experienced with the use of this product, and/or quality problems should also be reported to
the FDA's MedWatch Program by:
- Web: MedWatch website at www.fda.gov/medwatch
- Phone: 1-800-FDA-1088
- Fax: 1-800-FDA-0178, or by
- Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
If you have any questions regarding the products, please contact:
|BD Support Center
Phone hours: 7:00am to 4:00pm PT, Monday - Friday
|General Follow up or Product Notification Questions
|BD Customer Advocacy
Phone hours: 7:00am to 5:00pm PT Monday - Friday
|BD Technical Support
Phone hours: 6:00am to 5:00pm PT Monday - Friday
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