Events

Retiro De Equipo (Recall) de DXH 500

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECKMAN COULTER CANADA L.P..

¿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
    145041
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-07-19
  • 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
    A specimen misidentification may occur despite an active software prompt on the screen when the following sequence of events occurs: - pending test orders exist on the worklist - a new specimen id is added using the "next" icon on the sample analysis - patient results screen or by scanning a specimen barcode label - the user leaves the screen before aspirating the new specimen upon returning to the sample analysis - patient results screen the following prompt displays "worklist contains entries. confirm next specimen id is correct before processing specimen" - the next specimen id field of the dxh 500 defaults to the first specimen id on the worklist which may not be the newest specimen identified - the issue occurs when the user fails to verify the specimen id the issue does not occur when the worklist has no pending test orders.

Device

DXH 500
  • Modelo / Serial
    Model Catalog: B40601 (Lot serial: AZ08031)
  • Descripción del producto
    DXH 500
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC