Events

Retiro De Equipo (Recall) de ADVIA CENTAUR XP SYSTEM - INSTRUMENT CLASS III

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE LIMITED.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    129862
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-11-08
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    The wash interconnect circuit board on the advia centaur/advia centaur xp can fail due to contamination on the board during manufacturing and/or during use. when a failure occurs it is possible to have incorrect reporting of the wash1 sensors status. the fluid line of either sensor (s1 or s2) is reported to be empty when it is actually full or reported to be full when it is empty. these failures could either lead to the system not detecting an empty wash1 bottle or reservoir or stop the system from running due to a supposedly empty wash1 reservoir. if the sensors both fail in the "wet" state due to the board malfunction an erroneous but believable result may be released to the physician which is falsely high or low (depending on the assay architecture - competitive or sandwich).

Device

ADVIA CENTAUR XP SYSTEM - INSTRUMENT CLASS III
  • Modelo / Serial
    Model Catalog: 09066916 (Lot serial: ); Model Catalog: 078-A010-07 (Lot serial: ); Model Catalog: 04911855 (Lot serial: ); Model Catalog: 078-A001-14 (Lot serial: ); Model Catalog: 04911855 (Lot serial: >80 S/N CONTACT MANUFACTURER); Model Catalog: 078-A001-14 (Lot serial: >80 S/N CONTACT MANUFACTURER)
  • Descripción del producto
    ADVIA CENTAUR XP SYSTEM-INSTRUMENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC