Events

Edwards Fem-Flex II Femoral Arterial Cannula, sizes 8, 10 & 12 French 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-2015-RN-00294-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00294-1
  • 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 post market surveillance, edwards lifesciences has identified a potential health risk to patients regarding the use of fem-flex ii femoral arterial cannula, sizes 8, 10, and 12 french only. edwards has received one customer complaint regarding a released wire, located at the tip area of the cannula, which was identified prior to use. although the condition does not affect the functionality of the cannula, there is potential patient safety risk if a protruding wire is not detected prior to use. in a worst-case scenario, if the physician attempted to insert the device, the exposed wire could damage the femoral artery, causing a vascular injury that could require surgical or interventional repair.While there have been no reports of injury associated with this issue, edwards is taking this action to eliminate the chance of tissue damage caused by a protruding wire.
  • 조치
    All affected product is being Recalled from the Market. This action has been closed-out on 17/08/2016.

Device

Edwards Fem-Flex II Femoral Arterial Cannula, sizes 8, 10 & 12 French
  • 모델명 / 제조번호(시리얼번호)
    Edwards Fem-Flex II Femoral Arterial Cannula, sizes 8, 10 & 12 FrenchProduct Codes: FEMII008A, FEMII008AT, FEMII010A, FEMII010AT, FEMII012A & FEMII012ATARTG Number: 177959Product Codes: FEMII008V, FEMII010V & FEMII012VARTG Number: 142782Multiple lot numbers affectedARTG number: 142782
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd