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 Healthcare 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 021 03 17 001
  • 사례 시작날짜
    2017-07-08
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11260
  • 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
    Baxter ag is initiating a field action in order to update software versions of the prismaflex control unit. baxter has received reports of device operators failing to adhere to the instructions for use pertaining to the safe unloading of disposable sets from the prismaflex control unit. these steps are required to safely disconnect the patient before proceeding to unload the filter set after treatment. unloading of the disposable set without following the instructions and warnings on the prismaflex control units may lead to severe blood loss and potentially fatal outcomes. since 2012, baxter has received reports of six serious injuries and five patient deaths associated with this issue.

Device

Prismaflex System, Prismaflex 4.11, Prismaflex 5.00 Row, Prismaflex 6.10 Row and Prismaflex 7.XX ...
  • 모델명 / 제조번호(시리얼번호)
    Product Codes: 107493, 113082, 113874, 114489 and 114870. Serial Numbers: All
  • 제품 설명
    Continuous Renal Replacement Therapy (CRRT)
  • Manufacturer
    Baxter Healthcare

Manufacturer

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