Events

Alerte De Sécurité sur Product: SPECTRA OPTIA AFERESE SYSTEM. Model: AFERESE SPECTRA OPTIA SYSTEM. Anvisa Registration n ° 80554210002.

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
    1788
  • Date
    2016-01-12
  • 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
    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.
  • Cause
    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