Events

Safety Alert for AUTOMIX Automated Nutrition Mixer. Models: AUTOMIX, AUTOMIX 3 + 3, AUTOMIX PLUS, AUTOMIX 3 + 3 230V AND AUTOMIX 3 + 3 / AS.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Baxter Hospitalar Ltda.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1158
  • Date
    2012-08-02
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    According to the Company, a corrective action was initiated in March 2011 through a Letter of Communication to Customers, informing about a potential failure in the equipment keyboard. Subsequently, on 06/06/2012, the Company verified that this action was not effective and, in addition, identified that the AUTOMIX system could suffer an intermittent electric fault, which may cause a sudden and unexpected stop of the product - this may lead to interruption of the mixing process performed by the product, without any alarm or "green" warning light visible, without the operator detecting the fault.
  • Reason
    Possibility of intermittent electric failure.
  • Action
    The record holder started collecting the product. If you have any product affected by this field action in your inventory, check Baxter's recommendations for product use in the Letter to Customer. To access the Letter to the Client, use the following link: http://portal.anvisa.gov.br/wps/wcm/connect/e6fdba004c34776ca906f9dc39d59d3e/Mensagem_de_Alerta.pdf?MOD=AJPERES

Device

AUTOMIX Automated Nutrition Mixer. Models: AUTOMIX, AUTOMIX 3 + 3, AUTOMIX PLUS, AUTOMIX 3 + 3 23...

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA