Events

Alerta De Seguridad para BD PHOENIX SYSTEM - Registration No. 10033430436 - BD Model PHOENIX SYSTEM SOFTWARE 448035/448046 - Versions 5.55R, 5.56A, 5.70A, 5.75A, 5.83A and 6.01A ## MODEL BD PHOENIX UPDATE DISKS 441107/448047 - Versions 4.51 R, 4.65G, 4.61A, 4.65A, 4.71A, 4.75A, 4.81A, 4.91A, 5.11A, 5.15A and 5.21A - SERIAL NUMBERS: PX0658; PX0883; PX0909; PX0921; PX0926; PX0943; PX0947; PX0948; PX0968; PX0973; PX0975; PX0985; PX1017; PX1019; PX1107; PX1109; PX1128; PX1145; PX1146; PX1147; PX1148; PX1149; PX1353; PX1381; PX1392; PX1406; PX1407; PX1412; PX1494; PX1495; PX1496; PX1534; PX1535; PX1539; PX1581; PX1582; PX1597; PX1598; PX1623; PX1624 and PX1625.

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 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
    1130
  • Fecha
    2012-05-08
  • 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
    This situation, according to the company, affects only the results of SUSCEPTIBLE TO VANCOMYCIN or INTERMEDIATE SUSCEPTIBILITY TO VANCOMYCIN. All other results of VANCOMYCIN RESISTANT for E. faecium and all MIC / MIC results for organisms other than E. faecium continue to be interpreted correctly. See more in the attached file. http://portal.anvisa.gov.br/wps/wcm/connect/36a690004b2c453eace6afa337abae9d/Alerta_1130_Communicacao_de_Acao_de_Campo.pdf?MOD=AJPERES There are no records related to this problem in the NOTIVISA system. Anvisa follows this field action.
  • Causa
    An increase in enterococcus faecium strains that may exhibit incorrect results (interpretations of false susceptible or false intermediate) in the vancomycin well in phoenix pmic or pmic / id panels has been identified.
  • Acción
    The BD recommends that, until the Software update is made, users confirm all results WHICH MAY BE VOCCOMICINATED OR INTERMEDIATE SUSCEPTIBILITY TO VANCOMYCIN for E. faecium, generated by the BD PHOENIX SYSTEM with an additional alternative methodology, such as Disk Diffusion Method Etest. See more in the attached file. http://en.wikipedia.org/w/eng/index.php

Device

BD PHOENIX SYSTEM - Registration No. 10033430436 - BD Model PHOENIX SYSTEM SOFTWARE 448035/448046...

Manufacturer

BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA