Events

Alerte De Sécurité sur 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.

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 BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.

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
    1130
  • Date
    2012-05-08
  • 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
    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.
  • Cause
    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.
  • Action
    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