Events

Hemodialysis Monitor 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 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-00183-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00183-1
  • 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
    This recall is being initiated because of customer complaints indicating the inability to obtain measurements due to the device sometimes seeing no flow or irrelevant flow condition when used with patients during dialysis procedures. no reports of any injuries have been reported nor are expected due to the nature of this issue. the problem is readily identified to the user by a zero or a very low flow value displayed on hd03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac output).
  • 조치
    Emergo is advising their customers to discontinue the use of the monitor and contact Transonic customer service to arrange for replacement (repair/exchange) immediately. This action has been closed-out on 18/07/2016.

Device

Hemodialysis Monitor

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia