Events

Alerta De Seguridad para Volumet AGILIA VL ST, Model: VL ST01, VL ST02, Registration No. 10154450165 - lots: a) MODEL VL ST01: 71HF30DB00, 71HF30DB00, 71HF30D00, 71HF30DD00, 71HF30DD00, 71HH19DA00, 71HH19D0000, 71HH19D0000, 71HH19DD00, 71HI05DA00, 71HI05DB00, 71HI12DA00, 71HI09DA00, 71HI11DA00, 71HI15DA00, 71HI12DA00, 71HI16DA00, 71HI17DA00, 71HI18DA00, 71HI19DA00 -. b) TYPE VL ST02: 71HE31DF00, 71HE29DA00, 71HE31DF00, 71HE29DB00, 71HE30DA00, 71HE30DB00, 71HE30DC00, 71HE31DA00, 71HE31DB00, 71HE31DC00, 71HE31DD00, 71HG15DA00, 71HG15DC00, 71HG15DB00, 71HG15DB00, 71HG15DC00, 71HG17DA00, 71HG15DD00, 71HG17DB00, 71HG22DC00, 71HG22DD00, 71HG15DD00, 71HG17DA00, 71HG22DC00, 71HH19DI00, 71HH19DK00, 71HH21DB00, 71HH21DC00, 71HH26DC00.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Fresenius Hemocare Brasil 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
    1447
  • Fecha
    2014-10-17
  • 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
    According to the company, the divergence in information does not risk the patient, considering that the product is in fact free of DEHP. The divergence of information is in the place of symbols. The DEHP free information is correctly described on the label. The company also informs that this product is of exclusive use for pump of infusion and restricted to the hospital scope. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Causa
    The company informs that an error was identified in the labeling of the product. the product is exempt from dehp, and this information appears on the label, i do not understand in the area where the symbols of "barren, single-use product, keep out of moisture, among others" were misprinted, the symbol "contains dehp ". the difference in the contains and does not contain deph symbol is only a transverse trait.
  • Acción
    The company forwarded communication to customers who have already received the product stating the error.

Device

Volumet AGILIA VL ST, Model: VL ST01, VL ST02, Registration No. 10154450165 - lots: a) MODEL VL S...

Manufacturer

Fresenius Hemocare Brasil Ltda.