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 Terumo Cardiovascular Systems Corporation 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 105 08 17 000
  • 사례 시작날짜
    2017-08-30
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11475
  • 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
    This field safety notice calls attention to a situation that may arise with the ln130b over-pressure safety valve (ops valve) within your terumo extracorporeal tubing set or the lh130 single, sterile ops valve, and recommends how to check to ensure the duckbill valve within the ops valve is patent and allows flow through the valve. terumo cardiovascular systems (terumo cvs) has received reports of no flow through the ops valve. terumo cvs has received no reports of patient injury due to this issue.

Device

Over-Pressure Safety Valves
  • 모델명 / 제조번호(시리얼번호)
    - Please check attached file for all code numbers
  • 제품 설명
    Valves, Unidirectional Flow, Heart-Lung Bypass
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • 제조사 모회사 (2017)
    Terumo Corp.
  • 제조사 대표
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA