Events

HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as inflow or outflow cannula) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Maquet Australia 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-2012-RN-01015-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-10-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01015-1
  • 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
    In some very rare cases, it was not possible to insert the guide wire through the introducer of the hls-cannulae. the investigation identified that the hole in the grip of the introducer was partly blocked and the guide wire could not be pushed through. the problem occurs prior to vascular access and the cannulae itself functions properly during perfusion.
  • 조치
    Quarantine and return affected devices to MAQUET

Device

HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as ...
  • 모델명 / 제조번호(시리얼번호)
    HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as inflow or outflow cannula)Multiple catalogue and lot numbersARTG Numbers: 188929 and 189286
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd