Events

Artis Dialysis System equipped with SW 8.15.06 and 8.33.02 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-2015-RN-00057-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-01-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00057-1
  • 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
    Depending on the type of dialyzer membrane being used, excess foam may be generated in the venous circuit during patient connection and during the first few minutes of treatment. this specific condition is clearly visible to the operator.This issue was found to be primarily due to residual humidity in the fibers of the dialyzers with air permeable membranes. this problem has not been reported in dialyzers with non-air permeable membranes.None of the incidents reported resulted in a serious patient injury or medical intervention to preclude serious injury.
  • 조치
    An Operator Manual Addendum is being prepared and expected to be released Q3 2015. In the interim the Customer Letter details the new instructions. This action has been closed-out on 18/07/2016.

Device

Artis Dialysis System equipped with SW 8.15.06 and 8.33.02
  • 모델명 / 제조번호(시리얼번호)
    Artis Dialysis System equipped with SW 8.15.06 and 8.33.02ARTG Number: 141189
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd