Events

Alerta De Seguridad para Commercial name: Spectra Optia Apheresis System Technical Name: Apheresis System ANVISA Registration Number: 80554210002 Hazard Class: III Serial Numbers Affected: 1P04097

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Terumo BCT Tecnologia Médica Ltda.; Terumo BCT Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2319
  • Fecha
    2017-06-23
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    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.
  • Acción
    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.