Events

NxStage Express Fluid Warmer 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Regional Health Care Group 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-2018-RN-00798-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-06-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00798-1
  • 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
    Nxstage has identified a potential risk of electrical fire, in the event fluid leaks into the power receptacle on the back of the express fluid warmer. this risk exists at any time whilst the warmer is plugged in. nxstage has received 7 reports of smoke, sparks or flames coming from the express fluid warmer since 2016. there have been no adverse health consequences or medical interventions reported as a result of this issue.Given the occurrence of these incidents, the instructions for use (ifu) are being updated with a warning about fluid bags and fluid near the warmer, along with instructions on how to minimise this risk.
  • 조치
    NxStage, through Regional Health Care Group have taken the decision to replace the Instructions for Use with an updated IFU.

Device

NxStage Express Fluid Warmer
  • 모델명 / 제조번호(시리얼번호)
    NxStage Express Fluid Warmer Models: FW-300, FW-300-WW, FW-300-A, FW-301 and FW-301-AARTG Number: 289644(Regional Health Care Group - Conduction blood/fluid warmer)
  • Manufacturer
    Regional Health Care Group Pty Ltd

Manufacturer

Regional Health Care Group Pty Ltd