Events

Retiro De Equipo (Recall) de ALARIS PATIENT CARE SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER

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

¿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
    62679
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2009-07-13
  • 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
    1)occluded tubing may cause medication not to be delivered. 2)misprogrammed infusion caused by ignoring the warning message. 3) specific esd protection circuitry may result in an over or under infusion. 4)certain fluids solidify in the pumping mechanism. 5) iui connector failure when they become corroded or contaminated.

Device

ALARIS PATIENT CARE SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER
  • Modelo / Serial
    Model Catalog: 8015 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8110 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8650 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8600 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8120 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8300 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8220 (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8000APM (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8100LVP (Lot serial: MORE THAN 10 SERIAL NUMBERS); Model Catalog: 8210 (Lot serial: MORE THAN 10 SERIAL NUMBERS)
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Descripción del producto
    ALARIS PATIENT CARE SYSTEM-SERVER MODUL
  • Manufacturer
    CARDINAL HEALTH CANADA

Manufacturer

CARDINAL HEALTH CANADA
  • Dirección del fabricante
    VAUGHAN
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    HC