Events

Alaris® SmartSite® needle-free valve 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 CareFusion 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2014/017
  • 사례 연번
    CON418455
  • 날짜
    2014-05-21
  • 사례 출판 날짜
    2014-05-21
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON418455?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Risk of disconnection or inability to disconnect from the smartsite could result in delay to treatment due to: air entering the fluid path replacement of a central catheter or picc under-delivery and leakage of medication. carefusion issued a field safety notice (fsn) in february 2014 providing advice on this problem.
  • 조치
    Quarantine affected lot numbers of SmartSite as listed in the Field Safety Notice. Follow instructions in the FSN including returning verification form to CareFusion. Ensure all users are aware of manufacturer’s Field Safety Notice Arrange for replacement devices.

Device

Alaris® SmartSite® needle-free valve
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Alaris® SmartSite® needle-free valve Product reference: 2000E7D Specific lot numbers The Smartsite is a needle-free IV access device. Affected devices are made from a polycarbonate material. The affected lot numbers are: 13086202, 13086263, 13086309, 13095185, 13095913, 13095914, 13096487, 13096488, 13096489, 13105366, 13105478, 13106563, 13106710, 13106711, 13115316. If relevant to you, the national supply codes are as follows: England NPC: FSW165 Scotland SKU: 066032 Northern Ireland BSO: does not have a PALS reference number Wales NSV: FSN342 Only product code 2000E7D is affected and other configurations or item numbers are not affected. This Medical Device Alert does not affect CareFusion’s MaxPlus or MaxZero needle-free connectors.
  • Manufacturer
    CareFusion

Manufacturer

CareFusion