Events

Recall of Device Recall AUTOMIX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57790
  • Event Risk Class
    Class 2
  • Event Number
    Z-1383-2011
  • Event Initiated Date
    2011-01-27
  • Event Date Posted
    2011-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97445
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Set, i.V. Fluid transfer - Product Code LHI
  • Reason
    The automix compounder may not respond correctly to the key pressed by the operator using the keypad. the incorrect keypad response issue can occur both in manual data entry mode (std mode) and when entering order numbers to download from host software (man id mode). it is possible that an incorrect volume and/or an incorrect solution could be admixed into the final bag.
  • Action
    Baxter Healthcare Corp. sent Urgent Device Correction letters dated January 27, 2011, via first class mail to all affected customers. informing personnel that use Automix compounders to exercise care when entering data, and verify the accuracy of the keypad response. The accounts were requested to convey this information to all users of the Automix compounders, emphasizing the need to verify data accuracy each time the keypad is used. The accounts were also requested to complete the attached customer reply form listing the model and serial number of each of the Automix compounders at the facility and confirming their receipt of the letter, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to their local Baxter representative, and technical questions were directed to Baxter's Global Technical Services at 1-800-626-2667. After determining the root cause of the incorrect keypad responses, Baxter issued a follow-up correction letter on 4/27/11 outlining the recommended work practices to reduce fluid penetration into the Automix compounder keypad/control module.

Device

Device Recall AUTOMIX
  • Model / Serial
    Product codes 2M8077, all serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA - Nationwide including Puerto Rico, and internationally to Brazil, Canada, Colombia, Costa Rica, Czech Republic, El Salvador, Egypt, Germany, Guatemala, Honduras, Luxembourg, Mexico, Panama, Saudi Arabia, Singapore, Switzerland, Taiwan, Trinidad, Turkey, United Arab Emirates and United Kingdom.
  • Product Description
    AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 || The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA