Events

Alaris SmartSite Needlefree Connector 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-2014-RN-00119-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-02-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00119-1
  • 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 has identified potential risks with model code 2000e and lot numbers listed due to connection issues. the affected smartsite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. leakage may also be observed if the connector disconnects from the female luer during infusion. an inability to disconnect may require replacement of a line.
  • 조치
    Carefusion is requesting users to segregate and return unused stock of connectors with polycarbonate housing to Carefusion. Polycarbonate materials were introduced because they provide more resistance to isopropyl alcohol than the acrylic housing hub. Now that the 2000E polycarbonate version will no longer be available, please remind staff that when accessing the valve, remember to Swab The Hub every time, do not swab the whole body of the device and take care to follow instructions during connection and disconnection of the SmartSite connector.

Device

Alaris SmartSite Needlefree Connector
  • 모델명 / 제조번호(시리얼번호)
    Alaris SmartSite Needlefree ConnectorModel Number: 2000EBatch Numbers:13106451, 13046117, 13106355, 13045933, 13106754, 13086446, 13106753, 13096012, 13115734, 13095674, 13115872, 13095579, 13105584, 13095237, 13095913, 13106096, 13095914, 13095675, 13096488, 13106260 & 13106497ARTG Number: 189737
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd