Events

Alerte De Sécurité sur Blood Line for Transporting Blood in Hemodialysis Therapy - Record nº 80136990453 - lot: 13C09934

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 Laboratórios B. Braun S.A.; B.Braun Avitum AG.

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
    1394
  • Date
    2014-06-13
  • 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
    According to the manifestation of the company, the connection problem can cause a leak and, consequently, cause blood loss during therapy.
  • Cause
    The company that holds the registry informs about the possibility of disconnection, during dialysis therapy, of the glued joint between the pump segment and the blood line system. the cause is the lack of bonding of the pump segment that was inserted into the connector during the production process.
  • Action
    The company that holds the registration in Brazil requests the interruption of the distribution of said products / lots that are still in the customer's stock and segregation of the same, as well as the information to Laboratorios B. Braun SA of the quantities of existing units of each product code and lot number.

Device

Blood Line for Transporting Blood in Hemodialysis Therapy - Record nº 80136990453 - lot: 13C09934

Manufacturer

Laboratórios B. Braun S.A.; B.Braun Avitum AG