Events

Alerte De Sécurité sur SARNS ARTERIAL CANAL (Anvisa Record n ​​° 80012280001). LOTS AFFECTED: Code 12315, lots: 0652905; 0666574 / Code: 13010, lots: 0644444; 0646144; 0653230; 0666586 / Code: 13020, lots: 0570455; 0574279; 0640518; 0646396; 0666719 / Code: 13030, lots: 0570456; 0571580; 0640980; 0650900

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 CARDIOVASCULAR SYSTEMS; 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
    1140
  • Date
    2012-06-14
  • 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
    During production of a batch of the Sarns High Flow Aortic Cannula, the Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannula connectors. Terumo CVS's preliminary investigation has noted that the substance may be displaced from the surface of the cannula and is likely to be deposited during the molding process - the exact composition of the particle is still undetermined. While Terumo CVS has no other documented examples of this substance appearing during production, the company has determined that all units manufactured in the last three years in the same mold could have been potentially affected. For further information regarding this field action, please visit: http://portal.anvisa.gov.br/wps/wcm/connect/29cca4804b9e0545b6f7b6af8fded4db/Messagem_de_Alerta.pdf?MOD=AJPERES For Company Response Form, go to: http: / / /portal.anvisa.gov.br/wps/wcm/connect/f39d0f804b9e04c7b6d0b6af8fded4db/Formula_de_Resposta.pdf?MOD=AJPERES
  • Cause
    During the production of a product batch, terumo cardiovascular systems (terumo cvs) encountered a foreign substance on the outer surface of some cannula connectors.
  • Action
    According to Terumo it is a stock picking action (physical removal) from its point of use to some other location for destruction. If you have affected products in your facility, you must: (1) Review the Medical Device Removal notification; (2) Ensure that all users are aware of this notification; (3) segregate the identified affected products into your inventory; (4) Complete and return the Response Form (attachment) as soon as possible, indicating the number of units affected in your institution; (5) Contact Terumo Medicai do Brasil for local destruction instructions.

Device

SARNS ARTERIAL CANAL (Anvisa Record n ​​° 80012280001). LOTS AFFECTED: Code 12315, lots: 0652905;...

Manufacturer

TERUMO CARDIOVASCULAR SYSTEMS; TERUMO MEDICAL DO BRASIL LTDA