Events

Venous Arterial Aortic Cannula 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 manufacturer #121 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 연번
    2009DM-0004493
  • 날짜
    2018-04-16
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=50
  • 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

Device

Venous Arterial Aortic Cannula
  • 모델명 / 제조번호(시리얼번호)
    intra-aortic occlusion devices
  • 제품 설명
    ENDORETURN arterial cannula: is indicated for patients who undergo cardiopulmonary bypass. Its purpose is to deliver oxygenated blood for cardiopulmonary bypass during surgery. The ENDORETURN cannula with hemostasis valve allows catheter introducer: it is indicated for patients that require the introduction of catheters. Its purpose is the hemostatic introduction and removal of aortic catheter ENDOCLAMP from HEARTPORT. Arterial cannulaDIRECT: and the AUTOINCORTER are indicated for patients who experience cardiopulmonary bypass. The aim of the arterial cannula is to deliver oxygenated blood for cardiopulmonary bypass during surgery. AUTOINCYCOR: the AUTOINCORTER is intended to be used with the HEARTPORT arterial cannula. Its purpose is the incision of the aorta and the introduction of the cannula into the aorta. Arterial cannulaENDORETUM: is indicated for patients who experience a cardiopulmonary derivation. Its purpose is to deliver blood-oxygenated for cardiopulmonary bypass during surgery. The CANORETUM cannula with hemostasis valve allows the hemostatic introduction and removal of the ENDOCLAMP aortic catheter from HEARTPORT.Vain of the catheter introducer: it is indicated for patients requiring the introduction of catheters and the removal of the aortic catheterENDOCLAMP from HEARTPORT. Its purpose is the hemostatic introduction and removal of aortic catheter ENDOCLAMP from HEARTPORT. DIRECTFLOW arterial cannula: and the autoinclusor are indicated for patients who undergo cardiopulmonary bypass. The aim of the DIRECTFLOW cannula is to deliver oxygenated blood for cardiopulmonary diversion during surgery. The arterial cannula
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA