Events

Safety Alert for Syringe Pump DPS Module - Premium Base Accessory. Anvisa Record: 10004100141

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Fresenius Kabi 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
    891
  • Date
    2007-10-24
  • 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 company informed in a statement sent to the Anvisa's Technovigilance Unit that no incident involving the product has been reported, up to the present time. The update, according to the company, is a precautionary measure in order to further increase the safety profile of the device.
  • Reason
    Système pump software update prime base orchestra.
  • Action
    Fresenius Kabi has decided to update the Orchestra Base Primea - DPS Module Syringe Pump product software. According to the company, the customers involved will be notified and replacement will be given at no cost to them.

Device

Syringe Pump DPS Module - Premium Base Accessory. Anvisa Record: 10004100141

Manufacturer

Fresenius Kabi Brasil Ltda.
  • Source
    ANVSANVISA