Events

FOLFusor SV 0.5 ml/hr 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-2014-RN-00447-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-04-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00447-1
  • 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 direction insert for the folfusor sv 0.5 ml/hr states that infusion rates may be up to 10% greater than the nominal infusion rate of 0.5 ml/hr. flow rate testing indicates that infusion rates may be higher and could result in a 15% greater than nominal infusion rate.
  • 조치
    Baxter is notifying their customers that infusion rates may be higher and could result in a 15% greater than nominal infusion rate rather than 10% as stated in the IFU. Baxter is also reiterating the factors that can contribute to over infusion. These factors along with the 15% flow rate accuracy could result in infusion rates in excess of 30% greater than the nominal flow-rate. Baxter is currently investigating options to bring the flow rate into specification.

Device

FOLFusor SV 0.5 ml/hr
  • 모델명 / 제조번호(시리얼번호)
    FOLFusor SV 0.5 ml/hrProduct Code: 2C4700KAll lot numbers up to and including 14B039ARTG Number: 168893
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd