Events

Recall of Device Recall AUTOMIX 3 3/AS

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
    62558
  • Event Risk Class
    Class 1
  • Event Number
    Z-2142-2012
  • Event Initiated Date
    2012-07-13
  • Event Date Posted
    2012-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110988
  • 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
    System/device, pharmacy compounding - Product Code NEP
  • Reason
    After fluid ingress into the keypad of the automix compounder's (automix) control module, the automix may generate an incorrect device response to an automix operator's key press. also, the automix system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. also, the automix system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user.
  • Action
    Baxter Healthcare Corp. sent an Urgent Product Recall letters dated July 13, 2012, via first class mail to all affected customers, informing personnel that Baxter was executing a voluntary controlled product withdrawal of the Automix system from the U.S. market by June 1, 2013. Until their units can be replaced, customers were advised to exercise care when entering data, and verify the accuracy of the keypad response; to inspect the umbilical cable of the Automix for any visible cuts, nicks deformation, or physical damage to the cable, discontinuing use of the device if such damage is found; and to return the device to Baxter if the device stops compounding without an alarm and without a visible green complete light, discarding the solution bag. The customers were requested to convey this information to all users of the Automix compounders, and a wall chart was provided to hang over the device to remind users of the mitigations to take. The customers 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.

Device

Device Recall AUTOMIX 3 3/AS
  • Model / Serial
    Product code 2M8287, 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 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; || Product Usage: 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