Events

Safety Alert for FENWAL SEPARADOR AMICUS - Record # 10068390276

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
    810
  • Date
    2005-05-12
  • 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
    In October 2004, the company published a Technical Information document (No. 04-704A) on ammonia-based cleaning products and ammonia. The document informs that these cleaning products should NOT be used on any component of the AMICUS SEPARATOR, and recommended the use of mild soap / detergent. The document is available to customers through Baxter Hospitalar Ltda, telephone 0800-125522 option 3. If you have any questions or concerns about a related event, please contact Baxter Global Technical Services at 0800-125522 - option 3 and with ANVISA - Technovigilance Unit through telephonic 61 - 3448 1485 or tecnovigilancia@anvisa.gov.br.
  • Reason
    Since the launch of the amicus separator, baxter has been using a polycarbonate window in the centrifuge door. this window is protected by a sturdy coating. the company was informed, however, that some customers were using a chemical (specifically ammonia) to clean it. using this type of cleaning material can damage the centrifuge window. it can also accentuate cracks or cracks in the polycarbonate. so far there has been no news of any adverse events caused by this situation.
  • Action
    The company is replacing the centrifuge window of all AMICUS SEPARATOR instruments.

Device

FENWAL SEPARADOR AMICUS - Record # 10068390276

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA