Events

Alerta De Seguridad para ADVIA Chemistry XPT Technical Name: Biochemical Analyzer ANVISA Registration Number: 10345161947 Hazard Class: II Affected Model: ADVIA Chemistry XPT Affected Batch / Serial Numbers: CA1275001020102; CA1275001600160; CA1275001630163

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Inc..

¿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
    2096
  • Fecha
    2016-09-12
  • 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
    In order to avoid any possibility of inconsistent ISE results due to disconnected electrodes, make sure that the electrodes are fully connected after replacement, washing or maintenance activities by performing ISE calibration and processing of Quality Controls. If the electrode is not connected properly, the calibration will fail and the operator should perform the usual troubleshoot procedures. Perform the 2 levels of Quality Control at least once a day to confirm the perfect performance of the system.
  • Causa
    It is possible that the ise module will exhibit discrete unbonded results for sodium, potassium and chlorine when the respective electrode (including the reference electrode) remains switched off after replacement, washing or maintenance activities. the calibration and the 2 levels of quality control will fail if the electrode stays off. the instructions for use (ifu) for the ise electrodes clearly state the need to calibrate the ise after the replacement and processing of the two levels of control before testing the patient samples. after the special maintenance - wash, the online help documentation clearly informs the need to calibrate and process controls.
  • Acción
    Field Action Code CHI 15-03 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

ADVIA Chemistry XPT Technical Name: Biochemical Analyzer ANVISA Registration Number: 10345161947 ...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA