Events

COLLEAGUE volumetric infusion pump, ANVISA registration number 10068390320. 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
    836
  • 날짜
    2006-07-31
  • 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 Hospitalar Ltda has already begun corrections and updates of the COLLEAGUE infusion pumps in the country with an expected end in July 2007. The company also informs that there were no registered deaths in Brazil related to the equipment. Inquiries regarding COLLEAGUE pumps, please contact Customer Service at 0800 12 55 22, option 3. The Technological Surveillance Unit - UTVIG / NUVIG / ANVISA is following the actions of the company.
  • 원인
    Baxter healthcare corporation is providing a "global update" of colleague infusion pumps.
  • 조치
    Baxter Hospitalar Ltda informs that the "global update" corresponds to: 1. Replacing the User Interface Module printed on the circuit board to solve the Y2A crystal circuit event; 2. Install from a new version of the software to obtain the following: a. Limit the battery discharge after 3 minutes in the dead battery alarm status. B. Increase visual indicators and battery messages to allow a better understanding of current battery charge levels. w. Include a confirmation window that will appear when the user attempts to turn off the pump. d. Troubleshoot external communications port errors. 3. Replace battery wiring to the extent necessary to reduce the possibility of battery deformation. New batteries will be installed in the pumps as part of this action; 4. Modify the upper jaw of the pump pumping channel to reduce the possibility of insufficient infusion; 5. Perform a review of all pumps to ensure that all previous modifications have been made; 6. Provide with each pump a corrected Operator's Manual reflecting all the updates performed and where the instructions are clarified.

Device

COLLEAGUE volumetric infusion pump, ANVISA registration number 10068390320.

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA