Events

Primary PlumSet Clave secondary port 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Hospira 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/2013/079
  • 사례 연번
    CON335060
  • 사례 출판 날짜
    2013-11-13
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON335060?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 interruption to iv therapy, which may require medical intervention. this is due to leakage of fluids from the break in the bond between the clave needle-free connector and the secondary port of the plumset.  hospira issued a field safety notice (fsn) dated 8 august 2013 to advise users how to minimise the possibility of breakage, but has not received confirmation from enough users that they have received and acted on this information.
  • 조치
    Identify affected administration sets. Ensure that all users are aware of the recommendations given in the FSN. In particular, do not bend or twist the Clave needle-free connector when accessing the secondary port. Return the completed reply form to Hospira.

Device

Primary PlumSet Clave secondary port
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Intravenous administration sets: Primary PlumSet Clave secondary port. Specific list numbers are affected. All lots manufactured after July 2007 of the following list numbers have been supplied to the UK and are affected: 140010728 140018328 140019228 140149228 142129228 196735324 Note that any other list numbers detailed in the FSN have not been supplied to the UK
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • 제조사 모회사 (2017)
    Pfizer
  • Source
    MHRA