Events

Intra-aortic balloon pump CS300 의 안전성 경고

National Drugs Administration from El Salvador (DNM)에 따르면, 해당 안전성 경고 는 El Salvador 에서 Maquet 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 위험등급
    Class I
  • 날짜
    2017-06-16
  • 사례 국가
    El Salvador
  • 사례 출처
    DNM
  • 사례 출처 URL
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • 비고 / 경고
    Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
  • 데이터 추가 비고
  • 원인
    The cause of the sanitary wing is due to a valve failure that prevents the balloon from inflating and deflating properly. if a patient requires circulatory support with an iabp (balloon intra-aortic pump) and the device does not work, or if the treatment is stopped during use without a replacement iabp available, device failure may result in immediate adverse consequences and serious for health, including death. the sanitary registry im011319012017 covers the model cs300 visits the distributor's facilities and requested documentation of imports and stocks, where it was stated that no related imports had been made since 2012 and that the company's knowledge said affected equipment are outside of uses since they were replaced by more recent technology in 2016.
  • 조치
    Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment. - Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices

Device

Intra-aortic balloon pump CS300
  • 모델명 / 제조번호(시리얼번호)
    Sanitary DNM Registration Number: IM011319012017
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Maquet

Manufacturer

Maquet