Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1130
  • Date
    2012-05-08
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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