Events

Alerte De Sécurité sur PORTABLE SYSTEM OF REVERSE OSMOSIS. Anvisa Record: 80145240358. Product Codes: 5M5509, 5M5509R, 5M1313, 5M1313R, 5M1293 and FM4644.

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 Healthcare Corporation; 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
    948
  • Date
    2008-11-03
  • 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
    FILMTEC, a supplier of the FIL FILMTEC filter membranes for BAXTER, made changes to the instructions for use of the membranes. The new information contained in the instructions for use of these membranes is: (1) Saturated water obtained after the first hour of use should be discarded in the drain; and (2) Protective gloves and sleeves to avoid prolonged contact with skin and clothing. Users of the product are encouraged to read and perform these new operating instructions. To access the Letter to Clients disclosed by the company, access: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/948_carta.pdf
  • Cause
    Change of instructions for use of reverse osmosis membranes used in baxter's portable reverse osmosis system.
  • Action
    FILMTEC, a supplier of the FIL FILMTEC filter membranes for BAXTER, made changes to the instructions for use of the membranes. The new information contained in the instructions for use of these membranes is: (1) Saturated water obtained after the first hour of use should be discarded in the drain; and (2) Protective gloves and sleeves to avoid prolonged contact with skin and clothing. Users of the product are encouraged to read and perform these new operating instructions.

Device

PORTABLE SYSTEM OF REVERSE OSMOSIS. Anvisa Record: 80145240358. Product Codes: 5M5509, 5M5509R, 5...

Manufacturer

Baxter Healthcare Corporation; BAXTER HOSPITALAR LTDA.