Events

Safety Alert for Commercial name: Spectra Optia Apheresis System Technical Name: Apheresis System ANVISA Registration Number: 80554210002 Hazard Class: III Serial Numbers Affected: 1P04097

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
    2319
  • Date
    2017-06-23
  • 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
    MEASURES TO BE ADOPTED BY OUR CUSTOMERS 1) Distribute this notice to all users of the Spectra Optia Apheresis System within their organizations. 2) Continue to use the Spectra Optia Apheresis System as instructed in the operator's manual. 3) Important: Fill out the receipt form and send it signed to the email andrea.wecchi@terumobct.com as soon as possible. Sending this completed and signed form is essential to ensure that the information in this security alert has been received by all users.
  • Reason
    During routine testing of the manufacturing quality system, a terumo bct device that is similar to the spectra optia apheresis system demonstrated a non-recoverable power failure. a subsequent failure investigation determined that a power filter cable, a component used in the internal electrical system, had a visible defect causing the unit to lose power. further evaluation has determined that this defect may be present in other electrical cables that may cause a similar non-recoverable power failure. the cables were insulated in specific manufacturing batches. each spectra optia apheresis system also contains these cables described above. no other failures were noted in the manufacturing quality tests and there were no customer reports regarding a non-recoverable power failure related to any spectra optia apheresis system manufactured with the potentially affected cables.
  • Action
    Field Action Code FA 25 triggered under the responsibility of the company Terumo BCT Tecnologia Médica LTDA. Company will make correction in the field.

Device

Commercial name: Spectra Optia Apheresis System Technical Name: Apheresis System ANVISA Registrat...

Manufacturer

Terumo BCT Tecnologia Médica Ltda.; Terumo BCT Inc.