Events

Alerte De Sécurité sur CARDIOPLEGIA CANNES SARNS. Models: 203895, 203861 and 203887. Registry Anvisa: 80012280008. See list of affected lots in the Alert Message published by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/7c2181004c05651f8c4ddcdc39d59d3e/Message + of + Alert + 1150.pdf? MOD = AJPERES.

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 TERUMO MEDICAL 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
    1150
  • Date
    2012-07-17
  • 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
    Additional information in the Alert Message disclosed by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/7c2181004c05651f8c4ddcdc39d59d3e/Message+of+Alerta+1150.pdf?MOD=AJPERES. #### Update (01/11/2012): The company reported having located 296 affected units of the product remaining in the market. The date of destruction of these collected units will still be confirmed by the company. #### Update (09/04/2013): The field action was completed by the record holder on 11/27/2012. There were collected 276 units of product under risk, which were destroyed according to Certificates of Treatment presented by Terumo Medical do Brasil Ltda.
  • Cause
    Presence of foreign substance on surface of product.
  • Action
    It is a collection of product, aiming at its destruction. Check in your stock if you have products affected by this field action. If so, segregate and identify them to avoid inadvertent use, complete and submit the Response Form provided by Terumo and contact the company to receive instructions for the referral of the segregated products.

Device

CARDIOPLEGIA CANNES SARNS. Models: 203895, 203861 and 203887. Registry Anvisa: 80012280008. See l...

Manufacturer

TERUMO MEDICAL DO BRASIL LTDA