Events

IntraClude Intra-aortic Occlusion Device 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Edwards Lifesciences Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2018-RN-00313-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-04-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00313-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Edwards lifesciences has identified a potential safety risk, which may occur during the use of the intraclude intra-aortic occlusion device (icf100). edwards lifesciences has received a limited number of reports (11 reports since december 2017, which is a rate of approximately 2%) regarding inflation fluid leaking out the distal open end of the strain relief. when present, this leak can be identified through normal monitoring of balloon pressure.
  • 조치
    Edwards Lifesciences is advising users to maintain close vigilance of balloon pressure during a procedure in order to identify when additional volume is needed to maintain adequate occlusion. Consider having backup equipment available, such as aortic cross-clamps or additional IntraClude devices. Product return is not required at this time. Currently, unaffected product is not available.

Device

IntraClude Intra-aortic Occlusion Device

Manufacturer

Edwards Lifesciences Pty Ltd