Events

Safety Alert for FENWAL SEPARADOR AMICUS, model 4R4580, registration nº 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
    837
  • Date
    2006-07-31
  • 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
    Baxter Hospitalar Ltda has already sent a notice to all customers informing about the change of the manual. The company also informs that there was no complaint registered in Brazil related to the equipment. Inquiries or request copies of the changes, contact Baxter's Clinical and Technical Transfusion Therapy Division at 0800 937 5060. Company letter: http://www.anvisa.gov.br/tecnovigilancia/alertas/alerta835_anexo .pdf
  • Reason
    Possibility of return of the hemolysed blood to the donor after a specific maintenance procedure of the equipment.
  • Action
    Baxter is updating the Equipment Operation Manual. The maintenance step that guides users to lubricate the pump head will be excluded. Lubrication will be performed by Baxter's own staff during routine and / or preventive maintenance.

Device

FENWAL SEPARADOR AMICUS, model 4R4580, registration nº 10068390276.

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA