Events

Safety Alert for Enteromat Compact Infusion Pump, Registration 80136990431 - Number of series A4491, A4493, A4494, A4495, A4496, A4497, A4498, A4499, A4500, A4501, A4S02, A4503, A4504, A450S, A4558, A4559, A4560, A4561, A4562, A4590, A4590, A4590, A4590, A4590, A4590, A4570, A4510, A4590, A4522, A4524, A4523, A4524, A4524, A4524, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A445, A4552, A4553, A4554, A4555, A4556, A4557.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Laboratórios B. Braun S.A..

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
    1421
  • Date
    2014-08-19
  • 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
    According to the company's statement, all equipment was 100% evaluated before its release to the market, presenting results in accordance with the specifications defined therein, including calibration, ensuring that they are suitable for use. The company claims that the equipment complies with the specifications and there is no consequence in the use of the products.
  • Reason
    B. braun laboratories has identified that the certificates of the above serial numbers of the enteromat compact infusion pump equipment have been issued with incorrect information in the fields intended for calibration results. this is a human error, unique and exclusively related to the stage of issuing the certificates.
  • Action
    The company that holds the registration in Brazil requests the return of the incorrect Calibration Certificates that are in the possession of the customers, which will be replaced by the duly corrected revision.

Device

Enteromat Compact Infusion Pump, Registration 80136990431 - Number of series A4491, A4493, A4494,...

Manufacturer

Laboratórios B. Braun S.A.