Events

Safety Alert for Product: SPECTRA OPTIA AFERESE SYSTEM. Model: AFERESE SPECTRA OPTIA SYSTEM. Anvisa Registration n ° 80554210002.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Terumo BCT Tecnologia Médica Ltda; TERUMO BCT INC.

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
    1788
  • Date
    2016-01-12
  • 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, this possible error does not present risk to the functionality of the equipment. The error may occur in the following circumstances: (1) The user accidentally changes the weight and height values ​​when entering data into the Spectra Optia System; (2) The patient is weighed and measured in units that are different from those selected by the user in the equipment; (3) The user includes inaccurate height and weight data; (4) Abnormal calculation of the patient's total blood volume that may affect the outcome of the procedure.
  • Reason
    Alert on possible error in inclusion of user data records of patient weight and height in the spectra optia system, which would result in the abnormal calculation of the patient's total blood volume.
  • Action
    This is a safety alert from the company about the correct inclusion of information in the Spectra Optia system. Users should verify the correct entry of information relevant to the safety of the procedure. The TerumoBCT clinical experts were instructed to advise users to double-check the patient's weight and height prior to the start of the procedure. Company code for field action: FA 24

Device

Product: SPECTRA OPTIA AFERESE SYSTEM. Model: AFERESE SPECTRA OPTIA SYSTEM. Anvisa Registration n...

Manufacturer

Terumo BCT Tecnologia Médica Ltda; TERUMO BCT INC