Events

Safety Alert for (1) ADVIA 120 HEMATOLOGY SYSTEMS;

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BAYER CORP..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    71
  • Date
    2000-12-27
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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
  • Reason
    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.
  • Action
    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