Events

B. Braun Infusomat Space Infusion System (infusion pump) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 B Braun 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-2012-RN-00927-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-09-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00927-1
  • 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 is an expansion of a previous recall, initiated by b. braun in january 2012 due to the potential for breakage of the anti free flow clip located inside the infusion pump door. breakage may occur when the iv set anti free flow clip catch is inserted improperly into the pump and the pump door is forced closed. misloading of the anti free flow clip catch may create the potential for free flow of medication. free flow, specially of narrow therapeutic range drugs, can cause life-threatening effects and injuries.This recall action was not notified to the tga before it was initiated by b. braun.
  • 조치
    The sponsor will be providing a software and hardware update to mitigate the issue.

Device

B. Braun Infusomat Space Infusion System (infusion pump)
  • 모델명 / 제조번호(시리얼번호)
    B. Braun Infusomat Space Infusion System (infusion pump)Model Numbers: 8713050, 8713050-99, 8713050, 8713060U, 8713060U-99 with software version G03, G02 or olderAffected pumps were distributed from 6 November 2008 to 29 December 2011
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd