Events

Alerte De Sécurité sur Commercial name: Spectra Optia Apheresis System Technical Name: Apheresis System ANVISA Registration Number: 80554210002 Hazard Class: III Serial Numbers Affected: 1P04097

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Terumo BCT Tecnologia Médica Ltda.; Terumo BCT Inc..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2319
  • Date
    2017-06-23
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.