Events

Colleague Infusion Volumetric Pump, BAXTER Brand, Colleague Model, Colleague 3, Colleague CXE and Colleague CXE 3 - Registration Number 10068390320 /// Serial Number: 21120161DC, 22020018DC, 22030018DC, 22030000UC, 22040046UC, 22040071UC, 22040089UC, 22040104UC, 22050072DC, 22050406UC , 22060024DC, 22060720DC, 22060946DC, 22061138DC, 22061204DC, 22070050UC, 22070198UC and 22070444DC. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Baxter Hospitalar Ltda.; Baxter Healthcare SA Singapure Branch. 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
    1510
  • 날짜
    2014-12-16
  • 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
    According to manufacturer's information, using the Colleague infusion pump with old wiring may result in an inaccurate time remaining battery level or the option to operate with battery power may become unavailable. In the event of a failure or event with the battery (which is extremely unlikely to occur), this situation could contribute to a delay in infusion or interruption of the infusion.
  • 원인
    According to the information disclosed by the company, 18 serial numbers of the colleague pump were identified that had the "yuasa" battery replaced during service, but battery wiring was not changed as required in the specification.
  • 조치
    The company will correct the devices in the field and send Letter to the Client (SEE ANNEX) to those who have the equipment affected. Segregation of affected equipment is requested and completion of the Customer Response Form (APPENDIX). Once completed, send it to fax number 0 (XX) 11 5653-0106 or email faleconosco@baxter.com. LIST OF EQUIPMENT DISTRIBUTION IN ANNEX.

Device

Colleague Infusion Volumetric Pump, BAXTER Brand, Colleague Model, Colleague 3, Colleague CXE and...

Manufacturer

Baxter Hospitalar Ltda.; Baxter Healthcare SA Singapure Branch.