Events

Alaris GP Infusion set with Back Check Valve 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-01153-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-09-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01153-1
  • 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 manufacturer has received an increased rate of reports citing false upstream occlusion alarm of alaris gp sets with back check valve – 63420eb. these errors have been reported at flow rates below 250ml/hour. there is a risk that a clinician will not be able to start an infusion, or the infusion may be stopped due to an alarm, potentially resulting in a delay in therapy.
  • 조치
    BD is advising users to inspect inventory and quarantine any stocks of the affected lot numbers. Affected stock can be returned to BD for credit or replacement.

Device

Alaris GP Infusion set with Back Check Valve
  • 모델명 / 제조번호(시리얼번호)
    Alaris GP Infusion set with Back Check Valve Reference Number : 63420EBLot Numbers: 1000079, 1000169, 1000177, 1000321 ARTG Number: 125916
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd