Events

(1) ADVIA 120 HEMATOLOGY SYSTEMS; 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 BAYER CORP. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    71
  • 날짜
    2000-12-27
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    11.07.2001 - IN BRAZIL, THE ADVIA 120 HEMATOLOGICAL SYSTEM DOES NOT HAVE THIS AUTOMATIC DISCHARGE SYSTEM, WHICH IS USED ONLY THE DISPOSAL SYSTEM NOT INTEGRATED TO THE CENTRAL LABORATORY SEWER SYSTEM. FOR FURTHER INFORMATION CONTACT YOUR BAYER REPRESENTATIVE OR BY PHONE 011) -5694 5205
  • 원인
    A user of an advia 120 hematology system was accidentally blurred with the contents of waste tank because he did not release pressure before opening it. exposure to tank contents is a risk to health due to the potential contamination with viral and bacterial infectious agents. the diagnostic division of bayer began a correction to the user newsletter sent in may 2000. for the fact that other hematology systems, including technicon, incorporate pressurized waste tank, correction has been extended to also include these systems.
  • 조치
    CHECK THAT YOU HAVE RECEIVED CORRECTION BULLETIN AND MAY 2000 BAYER ALERT LABEL. IDENTIFY AND ISOLE THESE PRODUCTS WITH PRESSURIZED TANK FROM YOUR INVENTORY. ALERT LABELS ARE INTENDED TO EDUCATE THE OPERATOR NOT TO DISCONNECT THE WASTE CONTAINER LINES WHILE THEY ARE EMPTY OR UNDER PRESSURE, AND ALSO TO STRENGTHEN THE GUIDELINES ON THE INTERNET ADVIA 120, "AUTOMATED WASTE REMOVAL" IN THE CHAPTER "DAILY ROUTES - EMPTYING THE WASTE TANK" AND IN ALL THE TECHNOCON H MAINTENANCE DOCUMENTATION FOR REMOVAL OF WASTE. THE ALERT LABELS SHOULD BE: (10). CLEAN THE OUTSIDE OF THE TANK WITH ALCOHOL BEFORE PUTTING THE LABEL, (2O.) REMOVE FROM THE PAPER THE "WARNING: CAUTION" TRIANGULAR LABEL AND PUT IT INTO THE CONTAINER'S GASKET WASTE, (30) REMOVE PAPER FROM RECTANGULAR LABEL "CAUTION" BEYOND THIS CONTAINER. THE LABORATORY SHOULD ENSURE THAT ALL THESE CONTAINERS ARE PROPERLY LABELED. ADDITIONAL "ALERT" STICKERS MAY BE REQUESTED USING PN 100-1243-07 AND PN 067-1348-01, RESPECTIVELY.

Device

(1) ADVIA 120 HEMATOLOGY SYSTEMS;
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    BAYER CORP.

Manufacturer

BAYER CORP.
  • Source
    ANVSANVISA