Events

Retiro De Equipo (Recall) de Device Recall Colleague 3 and Colleague 3 CX Volumetric Infusion Pumps

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Baxter Healthcare Corp..

¿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
    32678
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1060-05
  • Fecha de inicio del evento
    2005-07-20
  • Fecha de publicación del evento
    2005-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40540
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    infusion pump - Product Code FRN
  • Causa
    A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes.
  • Acción
    Baxter sent the 7/20/05 Urgent Product Recall letter to all Colleague Infusion Pump customers, to the attention of the Director of Nursing and the Biomedical Engineer, via overnight delivery to alert them of a patient death which may have been associated with an electronic failure resulting from a design issue with the pump, and listed failure codes 402, 403, 532, 533, 534, 535, 702, 703, 704, 720, 804:22, 804:24, 804:29, 804:34, 804:52, 804:54, 804:58 and 12:303:xxx:0006 that may be related to the electronic failure. The users were advised to have a contingency plan to mitigate any disruptions of infusions of life sustaining drugs if the listed failure codes occur, and to take the pump out of service. They were also requested to review the event history of their pumps and take any pump with a previous history of the listed failures out of service. The accounts were also advised that all pumps processed through Baxter's service operations will be checked for the listed failure codes, and if a pump is found to have any of the codes in its event history, it will not be returned until a corrective action has been implemented. Any questions were directed to Baxter's Medication Delivery Services at 1-800-843-7867.

Device

Device Recall Colleague 3 and Colleague 3 CX Volumetric Infusion Pumps
  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA, Puerto Rico, United Kingdom, Canada, Brazil, Hong Kong, Taiwan, Turkey, Kuwait, South Africa, Chile, Saudi Arabia, Korea, Mexico, Colombia, New Zealand, the Bahamas, Belgium, El Salvador, Guatemala, Honduras, Israel, Lebanon, Panama, the Philippines and the United Arab Emirates.
  • Descripción del producto
    Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8153R, BRM8153(Brazilian Portugese), DNM8153(French), HNM8153(German), PNM8153(Spanish), CNM8153(Swedish), GNM8153(Danish), TRM8153(Turkish), WNM8153(Dutch) ,2M8163, 2M8163R
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Dirección del fabricante
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA