Events

Alaris GP Large Volumetric Pump (general purpose infusion pump) 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-2012-RN-01162-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-11-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01162-1
  • 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
    Carefusion, through its post market surveillance system, learned that the alaris gp infusion system produces very small air bubbles (less than 50ul) which are too small to trigger the lower configurable air-in-line detection thresholds (alarm) of the alaris gp infusion system - being 50-500ul, as configured by the user or 1ml over a rolling 15 min. window, which is considered state of the art and in compliance with en60601-2-24: particular requirements for the safety of infusion pumps and controllers (according to swissmedic).
  • 조치
    CareFusion is providing additional information and warnings in relation to at-risk groups of patients such as those with artial septal defect, neonates and those using multiple lines.

Device

Alaris GP Large Volumetric Pump (general purpose infusion pump)
  • 모델명 / 제조번호(시리얼번호)
    Alaris GP Large Volumetric Pump (general purpose infusion pump)Product Ref: 80063UN01, 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-GAll serial numbersARTG number: 130389
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd