Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Baxter Corp Canada 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
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 054 06 17 000
  • 사례 시작날짜
    2017-06-15
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11184
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    After a planned sharesource outage on may 28, 2017, three issues occurred: - the patient consent to share data was required, even though there was no revision of the patient consent content. a failure to submit a patient consent through the claria cycler resulted in patients being prompted to enter the patient activation code (pac) before each treatment, and no treatment data from the claria is shared with the clinic. - clinicians saw incorrect message “not for human use” on sharesource website. - some reviewed treatment history was not visible; those treatments were no longer marked as “reviewed”.

Device

Sharesource Claria Connectivity Platform for Use with Homechoice Claria APD System
  • 모델명 / 제조번호(시리얼번호)
    Product Code# 5CGM01
  • 제품 설명
    home dialysis therapy
  • Manufacturer
    Baxter Corp Canada

Manufacturer

Baxter Corp Canada
  • 제조사 모회사 (2017)
    Baxter International
  • 제조사 대표
    Arabian Health Care Supply Co. (AHCSC) Riyadh (01) 4747444
  • Source
    SFDA