Events

5008 PAED Therapy System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Fresenius Medical Care Australia 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-00885-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-07-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00885-1
  • 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
    The hd-paed option is available for dialysis 5008 systems for patients with a lower body weight. fresenius medical care has undertaken a review of the hazards identified with the use of the hd-paed option and determined that it is no longer possible to uphold the currently defined lower limit of 10 kg of body weight in the intended use for a safe application. as a result, fresenius medical are limiting the intended use to = 17 kg of body weight.To date, no related incidents for patients between 10kg and 40kg have been reported.
  • 조치
    Fresenius Medical Care is advising that the intended use of the HD-PAED option has been revised to = 17 kg of body weight. The Instructions For Use (IFU) of the 5008 Paediatric Haemodialysis Therapy System will be adapted accordingly. Customers are requested to exchange the relevant page in the IFU with the addendum included with the Customer Letter.

Device

5008 PAED Therapy System
  • 모델명 / 제조번호(시리얼번호)
    5008 PAED Therapy SystemARTG Number: 120309(Fresenius Medical Care Australia Pty Ltd - Haemodialysis Machines - Haemodialysis unit)
  • Manufacturer
    Fresenius Medical Care Australia Pty Ltd

Manufacturer

Fresenius Medical Care Australia Pty Ltd