Events

PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets 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-2014-RN-00785-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00785-1
  • 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
    Gambro has learned of difficulties of disconnection and/or leaks at the level of luer connections on disposable prisma, prismaflex, x-mars and adsorba sets. these conditions may occur when liquid is present on the male or female parts of the luer connector before connection (resulting, for example, from use of disinfectant or drops of priming or dialysate solution) and the wet connector is screwed by using the body of the luer connectors for tightening instead of screwing the coupling nut. under these circumstances, the fluid on the cone can act as a lubricant and might lead to an over-tightening of the connection. the resulting luer connection may be difficult to disconnect and the male luer lock may break when applying a high mechanical force.
  • 조치
    This action has been closed-out on 01/11/2017.

Device

PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets
  • 모델명 / 제조번호(시리얼번호)
    PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd