Events

Edwards Lifesciences QuickDraw Venous Cannula 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-2013-RN-00524-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-05-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00524-1
  • 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
    Through routine post market surveillance data review, edwards lifesciences has identified new risks associated with specific removal techniques for the quickdraw venous cannula product:1. scar tissue at the incision site may create resistance and increase the withdrawal forces on the cannula.2. when using the percutaneous technique; separation of the cannula may occur during removal if too much compressive force is applied at the incision site. this is in addition to the resistance felt if scar tissue is present.
  • 조치
    Edwards Lifesciences is asking customers to quarantine any affected product and return these. Cautions for these new risks are being added to the IFU for future shipments of the cannula to provide information to users about this potential risk.

Device

Edwards Lifesciences QuickDraw Venous Cannula

Manufacturer

Edwards Lifesciences Pty Ltd