Events

COLLEAGUE Volumetric Infusion Pump Mono Channel and Triple Channel. ANVISA Register: 10068390320. Product Codes: 2M8151, 2M8151R, 2M8151RT, BRM8151, BRM8151R, BRM8151RT, 2M8153, 2M8153R, 2M8153RT, BRM8153, BRM8153R, BRM8153RT. 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
    956
  • 날짜
    2009-03-09
  • 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
    Baxter is currently developing solutions for correcting the events reported in this letter. The instructions attached to this letter describe further steps to remedy a discontinuation of therapy if it occurs. The ANVISA Technovigilance Unit is monitoring this case.
  • 원인
    1 ° problem: some error codes shown by colleague infusion pumps can lead to interruption of therapy (infusion), which can lead to complications in critically ill patients, including serious injury or death. 2 ° problem: risks associated with inadequate cleaning procedures. 3 ° problem: occurrence of "out of battery" messages.
  • 조치
    The actions recommended to users for each of the reported problems are described in detail in the Letter to Users. Users of COLLEAGUE infusion pumps who do not have a copy of said letter should access it (available at http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/956_carta.pdf) and carefully read all instructions, taking the necessary measures to correct / prevent the problems mentioned in this alert.

Device

COLLEAGUE Volumetric Infusion Pump Mono Channel and Triple Channel. ANVISA Register: 10068390320....

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA