Events

Alerta De Seguridad para Commercial name: BD Phoenix Gram Negative /// Technical name: Identification device / antibiogram of microorganisms /// ANVISA registration number: 10033430636 /// Risk class: II /// Whereas cefepime is present in BD Phoenix panels Gram Negatives, all panels that are already used, ie panels already registered with ANVISA, and potential panels to be used, ie panels that are to be registered, were included in the Client Notification. Registered panels: BD Phoenix NMIC / ID - 123; BD Phoenix NMIC-123; BD Phoenix NMIC-129; BD Phoenix NMIC / ID-124; BD Phoenix NMIC / ID-126; BD Phoenix NMIC / ID-129; BD Phoenix NMIC / ID-132; BD Phoenix NMIC-133; BD Phoenix NMIC / ID-121; BD Phoenix NMIC-140; BD Phoenix NMIC / ID-94; BD Phoenix NMIC - 203 // Panels to be registered: BD Phoenix NMIC / ID-406; BD Phoenix NMIC-406; BD Phoenix UNMIC / ID-407; BD Phoenix UNMIC-407.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Becton Dickinson and Company; Becton Dickinson Indústrias Cirúrgicas Ltda.

¿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
    1984
  • Fecha
    2016-09-14
  • 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
    The BD recommends that the lab verify the current BD Phoenix System settings to ensure that the default configuration has not been modified. If the rules specified in the letter sent to users are disabled, BD recommends that the default setting be restored.
  • Causa
    The company states that "a new strain isolate of klebisiella pneumonia has been identified. the new isolate presents a change in the susceptibility test to cefepime present in phoenix gram negative panels. the new isolate may give a false susceptible result. after investigation with several strains of this microorganism it was concluded that the phoenix system and the panels continue to perform as expected and that the possible change in the susceptibility test occurs as a function of the change of the microorganism.
  • Acción
    The company informs that the data of the BD Phoenix Gram negative panels are performing as expected, as there was a change in the strain of the microorganism. Therefore these Products are not under risk. Also regarding the possibility of release of false susceptible result, the Phoenix BD System has features that automatically correct the result or send alert message to the health professional of the Laboratory. Assuming that a false susceptible result is released, the risk is associated with inappropriate antibiotic use.

Device

Commercial name: BD Phoenix Gram Negative /// Technical name: Identification device / antibiogram...

Manufacturer

Becton Dickinson and Company; Becton Dickinson Indústrias Cirúrgicas Ltda