Events

Alerte De Sécurité sur Enteromat Compact Infusion Pump, Registration 80136990431 - Number of series A4491, A4493, A4494, A4495, A4496, A4497, A4498, A4499, A4500, A4501, A4S02, A4503, A4504, A450S, A4558, A4559, A4560, A4561, A4562, A4590, A4590, A4590, A4590, A4590, A4590, A4570, A4510, A4590, A4522, A4524, A4523, A4524, A4524, A4524, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A4552, A4553, A4554, A4555, A4556, A4557.

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..

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
    1421
  • Date
    2014-08-19
  • 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 company's statement, all equipment was 100% evaluated before its release to the market, presenting results in accordance with the specifications defined therein, including calibration, ensuring that they are suitable for use. The company claims that the equipment complies with the specifications and there is no consequence in the use of the products.
  • Cause
    B. braun laboratories has identified that the certificates of the above serial numbers of the enteromat compact infusion pump equipment have been issued with incorrect information in the fields intended for calibration results. this is a human error, unique and exclusively related to the stage of issuing the certificates.
  • Action
    The company that holds the registration in Brazil requests the return of the incorrect Calibration Certificates that are in the possession of the customers, which will be replaced by the duly corrected revision.

Device

Enteromat Compact Infusion Pump, Registration 80136990431 - Number of series A4491, A4493, A4494,...

Manufacturer

Laboratórios B. Braun S.A.