Events

FENWAL SEPARADOR AMICUS - Record # 10068390276 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Baxter Hospitalar 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
    810
  • 날짜
    2005-05-12
  • 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
    In October 2004, the company published a Technical Information document (No. 04-704A) on ammonia-based cleaning products and ammonia. The document informs that these cleaning products should NOT be used on any component of the AMICUS SEPARATOR, and recommended the use of mild soap / detergent. The document is available to customers through Baxter Hospitalar Ltda, telephone 0800-125522 option 3. If you have any questions or concerns about a related event, please contact Baxter Global Technical Services at 0800-125522 - option 3 and with ANVISA - Technovigilance Unit through telephonic 61 - 3448 1485 or tecnovigilancia@anvisa.gov.br.
  • 원인
    Since the launch of the amicus separator, baxter has been using a polycarbonate window in the centrifuge door. this window is protected by a sturdy coating. the company was informed, however, that some customers were using a chemical (specifically ammonia) to clean it. using this type of cleaning material can damage the centrifuge window. it can also accentuate cracks or cracks in the polycarbonate. so far there has been no news of any adverse events caused by this situation.
  • 조치
    The company is replacing the centrifuge window of all AMICUS SEPARATOR instruments.

Device

FENWAL SEPARADOR AMICUS - Record # 10068390276

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA