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 Codan Argus AG 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 057 05 14 000
  • 사례 시작날짜
    2014-05-13
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=5823
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    The basis of this field safety notice are pertaining to the frequent technical errors #8123 and #8129 on codan argus 717v infusion pumps. technical errors #8123 and #8129 originate from the self-test of the down-stream pressure sensor. analysis by the manufacturer revealed that apart from broken pressure sensors, excessive hardness of the intravenous infusion set could trigger these technical errors. the technical errors occur once the intravenous infusion set is inserted and the user closes the pump door - before the infusion is started. any such delay of infusion or interruption of therapy through a false infusion pump alarm, which may potentially put the patient’s health at risk, is unacceptable. unanticipated variations of the mechanical properties of the intravenous infusion sets were identified as the root cause of above mentioned false technical errors.

Device

Infusion pump CODAN ARGUS 717/718V
  • 모델명 / 제조번호(시리얼번호)
    Control software version 5.05
  • 제품 설명
    Infusion pump, multifunction
  • Manufacturer
    Codan Argus AG

Manufacturer

Codan Argus AG
  • 제조사 모회사 (2017)
    Codan Argus Ag
  • 제조사 대표
    Al-Jeel Medical & Trading Co. LTD, Riyadh (011) 4041717
  • Source
    SFDA