Events

Alaris System Infusion PC Unit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 CareFusion Australia 316 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-2016-RN-00793-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00793-1
  • 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
    Alaris pc units model 8015 manufactured between september 11, 2012 and march 29, 2013 may display a system error code 133.6080 due to a failure with the super capacitor (c245) at power up on the alaris pc unit logic boards. the error code will cause an audible and visual alarm to sound and could cause a delay of therapy at power up only. the error code will not occur during infusion.
  • 조치
    Carefusion is advising users that if the error code is observed, to remove the unit from use and use a different unit where available. Carefusion will be correcting all affected units.

Device

Alaris System Infusion PC Unit
  • 모델명 / 제조번호(시리얼번호)
    Alaris System Infusion PC UnitModel Number: 8015Manufactured between 11 September 2012 and 29 March 2013ARTG Number: 146664
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd