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 BCT Inc. 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 056 12 18 000
  • 사례 시작날짜
    2018-12-16
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13621
  • 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 letter provides information about the new iv pole collar accessory for the trima accel system. new trima accel systems will be shipped with an iv pole collar (see figure 1 in the attached fsn). this feature has been added to avoid a pinch point between the iv pole cross bar and the machine while lowering the iv pole. on new machines, the service technicians will attach the iv pole collar to the iv pole during installation. if the operator does not hold onto the iv pole while pressing the iv pole release button, the iv pole may drop in a free fall. if the operator’s hand or any other body part is in the path of the free-falling iv pole, the operator could be injured. because this is an added safety feature, do not remove the collars after they are installed on the iv pole.

Device

Trima Accel® Automated Blood Collection System
  • 모델명 / 제조번호(시리얼번호)
    Trima Accel® Automated Blood Collection System
  • 제품 설명
    Apheresis Units, Blood Donor
  • Manufacturer
    Terumo BCT Inc.

Manufacturer

Terumo BCT Inc.
  • 제조사 모회사 (2017)
    Terumo Corp.
  • 제조사 대표
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA