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 Medtronic 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 045 02 18 000
  • 사례 시작날짜
    2018-02-13
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12121
  • 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
    In recent years, safety issues have been raised by regulators, including fda, regarding water system quality of temperature controllers, regardless of the manufacturer. the concern stems from the potential for bacterial growth in the water systems that can be transmitted to patients during surgery, and is likely related to the recommended water system cleaning practices and protocols employed. medtronic distributed bio-cal devices to the marketplace between 1989 and 2011. as of january 31, 2018, there have been two complaints received that suggest patients acquired a serious infection while undergoing surgery when a bio-cal device was being utilized. these complaints were received from a single customer in 2015. although a direct causal connection between the patient infection and the bio-cal could not be confirmed, the infection type was consistent with a waterborne bacterium (mycobacterium abcessus) and could have been attributed to the site’s cleaning and disinfecting of the device prior to use.

Device

Bio-Cal Temperature Controller
  • 모델명 / 제조번호(시리얼번호)
    Model Number 370 and 370I
  • 제품 설명
    Heart-lung bypass system module, temperature control unit
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • 제조사 대표
    Medtronic Saudi Arabia
  • Source
    SFDA