Events

Alerta De Seguridad para (1) ADVIA 120 HEMATOLOGY SYSTEMS;

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BAYER CORP..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    71
  • Fecha
    2000-12-27
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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
  • Causa
    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.
  • Acción
    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;

Manufacturer

BAYER CORP.
  • Source
    ANVSANVISA