Events

Alerte De Sécurité sur External sewage pump Architect no. List 8C94-99. External sewage pump Aeroset no. List 9D61-01

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 Abbott Laboratórios do Brasil 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
    713
  • Date
    2003-03-26
  • 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
    For laboratories that do not use an external sewage pump, there are no actions to be taken. There are no maintenance procedures that require operator intervention at the pump. Caution: When handling the sewage pump, ensure that adequate personal protective equipment is used. As a precaution, avoid contact with the metal end of the external sewage pump.
  • Cause
    The abbott laboratories - diagnostic division has identified a potential risk in handling the external sewage pump used in the architect and aeroset systems. this pump is an optional component for use in architect and aeroset systems. the metal end around the perimeter of the sewage pump can cause scratches or cuts if not handled with care.
  • Action
    Corrective actions are being implemented to eliminate this potential risk. External sewage pumps currently in use will be reviewed by ABBOTT representatives for removal of any end that poses a potential hazard.

Device

External sewage pump Architect no. List 8C94-99. External sewage pump Aeroset no. List 9D61-01

Manufacturer

Abbott Laboratórios do Brasil LTDA
  • Source
    ANVSANVISA