Events

Alerte De Sécurité sur FENWAL SEPARADOR AMICUS - Record # 10068390276

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Baxter Hospitalar Ltda.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    810
  • Date
    2005-05-12
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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