Events

Clearlink System Solution Set (Infusion administration set) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Baxter Healthcare 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-2013-RN-00741-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-07-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00741-1
  • 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
    Baxter anz received feedback from a customer that an iv tube could not be loaded into an infusion pump because the slide clamp was not correctly assembled. baxter facility received the complaint sample and confirmed the slide clamp had been assembled in the reverse direction. the incorrect assembly would lead to incorrect direction of infusion such that blood may be withdrawn from a patient and result in acute blood loss and/or delay in treatment of life sustaining medication as a worse case scenario.
  • 조치
    Baxter Healthcare are advising customers to remove affected product from use and return to Baxter for credit.

Device

Clearlink System Solution Set (Infusion administration set)
  • 모델명 / 제조번호(시리얼번호)
    Clearlink System Solution Set (Infusion administration set)Product Code: FNC3110Lot Numbers: SR13A04021, SR13A02041, SR13A07032 (Expiration date: Jan 2018), SR13B14077 (Expiration date: Feb 2018)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd