Events

Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tubing set)BL200 BD Pre Post 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Gambro 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-00086-2
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-02-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00086-2
  • 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
    Gambro has identified a potential for increased likelihood of clotting following the introduction of the new venous chamber on conventional bloodlines which are used with the integra and ak machines. the new venous chamber design may increase the likelihood of clotting due to the presence of potentially stagnant areas beside the blood flow inlet.
  • 조치
    Gambro is providing additional instructions for use for the correct blood level setting in the venous chamber. In addition, Gambro will discontinue the new design and re-introduce the original design.

Device

Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tub...
  • 모델명 / 제조번호(시리얼번호)
    Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tubing set)BL200 BD Pre Post;Product Code 114635, Batch Numbers from 1240 to 1303BL208BD;Product Code:114557Batch numbers from 1242 to 1304BL223 PB;Product Code: 114636Batch Numbers from 1252ARTG Number: 141589
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd