Events

Retiro De Equipo (Recall) de COLLEAGUE GUARDIAN ENHANCED CXE COLOR PUMP

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

¿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
    30851
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-09-19
  • 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
    Baxter will commence a remediation strategy whereby all current colleague pump customers will be provided with a newly manufactured colleague p1.7a pump software version 8.01.90 (en) or 8.11.90 (fr) in exchange for each existing pump with an earlier software version. this remediation is being conducted to correct pump issues previously communicated on january 29 2009 (recall number 45280 baxter reference 2008fca18) and to provide other software and mechanical upgrades.

Device

COLLEAGUE GUARDIAN ENHANCED CXE COLOR PUMP
  • Modelo / Serial
    Model Catalog: 2M9161 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM 8153 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8151 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8153K (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8153 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M9163 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8163 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8151K (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8161 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM 8151 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM9161 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM9163 (Lot serial: >100 NUMBERS CONTACT MFR)
  • Descripción del producto
    COLLEAGUE GUARDIAN ENHANCE CXE COLOR
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION