Events

unkown device 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 manufacturer #17429 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/2012/009
  • 사례 연번
    CON143805
  • 날짜
    2012-03-01
  • 사례 출판 날짜
    2012-03-01
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON143805?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
    Smiths medical has become aware of an increase in the number of reports of disconnections of the luer lock connector at the patient end of the tubing for these fluid warming sets. this can lead to a risk of fluid/ blood loss or delay in therapy. the mhra cannot be confident that these recalls have been effective and that users have received and acted on the information provided in the manufacturer’s field safety notices (fsns).
  • 조치
    Do not use the affected devices. Contact Smiths Medical to arrange the return and replacement of the affected sets as advised in the two Smiths Medical Field Safety Notices (FSNs) issued on 28 November 2011 for: Level 1® Hotline®         The FSNs list the lot numbers of all affected devices. Send the confirmation return form to Smiths Medical. Action by All those involved in the supply and use of these devices.

Device

unkown device

Manufacturer

manufacturer #17429