Events

thoracic drains Atrium 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Atrium Medical Corporation 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
    I1612-584
  • 사례 연번
    2008DM-0001833
  • 날짜
    2016-12-16
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=108
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer states that the deadvertence labels are being revised for the labeling of the chest drains, in order to inspect the current configuration of the container, clarifying that part of it is sterile, the affected product is packaged with a sterile double sequential wrap, a cover is placed external protective dust, and then bends and secures with the packaging label, the drain is sterile inside the container but the external dust cover is not, leading to possible serious adverse events on the patient.

Device

thoracic drains Atrium
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    ATRIUM thoracic drains are non-invasive disposable systems of multi-chamber vessels with valves, port and suction regulators, fluid or air collection chamber, vacuum and leakage indicators and suction connectors designed to: evacuate fluids or air from the chest cavity or mediastinomediante succión and collect them in the container or chamber ofdesecho. Help restore the lungs expansion and restore respiratory dynamics, by means of the achieved drainage. Facilitate the early evaluation of postoperative patients who require chest drainage, through the achieved drainage.
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation