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 Radiometer Medical 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 001 02 11 000
  • 사례 시작날짜
    2011-02-01
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=102
  • 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: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    (in january 27 , 2011 ) sensor cassette 946-008 lot r0031 has been found to exceed specifications for the parameters ph, k, na, ca and cl. the error resembles a positive bias on the reference electrode, increasing in size from installation of the cassette. the resulting parameter bias is of the order of 9 mmol for sodium, 0,1 mmol for calcium, 0,2 mmol for potassium, -0,018 for ph and -7 mmol for chloride. two incidents regarding lot r0031 were reported from the field, one from belgium (radiometer ref. rbnl 576990103) and one from finland (radiometer ref. trio 579829752). no reports of death or serious injury were received, but the chemist at the finnish hospital suspects that patients could have been maltreated. the clinical risk assessment of the belgian incident states that the error could lead to clinical serious misinterpretation and mal-therapy in the critical care setting if it should happen again.

Device

Blood Gas Analyzers - ABL90 FLEX
  • 모델명 / 제조번호(시리얼번호)
    ABL90 FLEX and accessory SC90 946-008 sensor cassette Software version: 2.4.1680.25 Lot/batch no.: R0031
  • 제품 설명
    Metabolic profile clinical chemistry analyser IVD, stationary, automated
  • Manufacturer
    Radiometer Medical

Manufacturer

Radiometer Medical
  • 제조사 모회사 (2017)
    Danaher Corporation
  • 제조사 대표
    Salehiya Trading Est., Riyadh, (01) 2628939
  • Source
    SFDA