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
    17878
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-18
  • 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 is notifying users of a range of potential issues that may be observed with colleague p1.5 volumetric infusion pumps. these issues include: occlusion detection sensor failure caused by fluid ingress variations in pump accuracy if a pump is dropped an electric circuit that does not comply with international safety standards an internal communication failure that will result in pump shutdown (see 2008fca18) and various battery maintenance problems (see 2008fca18).

Device

COLLEAGUE GUARDIAN ENHANCED CXE COLOR PUMP
  • Modelo / Serial
    Model Catalog: 2M9161 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8151 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8163R (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8163 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8153R (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8153KL (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: DNM9161 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM 8151R (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: DNM 8151 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8161R (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8161 (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8151R (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: 2M8151KL (Lot serial: >1000 NUMBERS CONTACT MFR);
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION