Events

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. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 TERUMO MEDICAL DO BRASIL LTDA 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1150
  • 날짜
    2012-07-17
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.
  • 원인
    Presence of foreign substance on surface of product.
  • 조치
    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