Events

Safety Alert for Ultrafilter U9000. Anvisa Registry n ° 10395890074.

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

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
    1450
  • Date
    2014-10-24
  • 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
    The U9000 ultrafilter is used in the Gambro / Hospitalar hemodialysis delivery systems to purify the admitted water as well as to obtain a high quality dialysis fluid that meets the microbiological requirements. Check additional information in the Safety Notice released by the product registration holder, available at: http://portal.anvisa.gov.br/wps/wcm/connect/ef22e90045fc3954a835ac7ffa9843d8/Assessment+of+Seguran%C3%A7a.pdf? MOD = AJPERES Check also the letter-response model prepared by the company for this field action, available at: http://portal.anvisa.gov.br/wps/wcm/connect/29d6610045fc39e9a83eac7ffa9843d8/Carta-resposta.pdf?MOD = AJPERES
  • Reason
    The u9000 ultrafilter housing is made of polycarbonate, a material known to undergo slow chemical degradation during prolonged exposure to alkaline substances. the intensive use of sodium carbonate-based disinfection programs over several months can thus cause degradation of the ultrafilter housing, leading to external fluid leakage at the weld site between the filter housing and the top cover.
  • Action
    Updating, correcting or supplementing the instructions for use.

Device

Ultrafilter U9000. Anvisa Registry n ° 10395890074.

Manufacturer

GAMBRO DO BRASIL LTDA.