Events

Retiro De Equipo (Recall) de Device Recall Colleague, Colleague CX and CXE 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
    50839
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1037-2009
  • Fecha de inicio del evento
    2009-01-23
  • Fecha de publicación del evento
    2009-03-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77460
  • 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
    Pump, infusion - Product Code FRN
  • Causa
    Baxter has identified failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the colleague infusion pumps.
  • Acción
    Baxter Healthcare Corporation sent an "Urgent Device Correction" letter dated January 23, 2009 to all Colleague Infusion Pump customers, to the attention of the Vice President of Nursing with copies to the Chief Operating Officer, Director of Biomedical Engineering and Director of Risk Management to advise them of failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages associated with the Colleague pumps. The letters listed the failure codes involved that lead to an interruption of therapy which could lead to serious injury and/or death; advised institutions to have contingency plans to verify that back-up pumps are available; and provided steps for addressing an interruption of therapy with any failure code. The letters also provided information about the hazards associated with improper cleaning of the pumps and instructions for addressing damaged battery messages. Customers were instructed to complete the attached Customer Reply Form acknowledging receipt of the letter and fax it to 888-569-1585. Direct questions to your local Baxter Representative or to Baxter Global Technical Services by calling 1-800-843-7867, Prompt 2, between 7AM and 5 PM Central Standard Time (CST).

Device

Device Recall Colleague, Colleague CX and CXE Volumetric Infusion Pumps
  • Modelo / Serial
    All product numbers and all serial numbers.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide including USA, Puerto Rico, Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Canada, Cayman, Chile, China, Colombia, Curacao, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Honduras, India, Ireland, Israel, Italy, Jamaica, Korea, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Qatar, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, United Kingdom and Venezuela.
  • Descripción del producto
    Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore. Product Codes: 2M8151, 2M8161, 2M9161, DNM8151, DNM9161, BRM8151, BRM8151T, BRM8151RT, PNM8151, PNM8151T, PNM8151RT, CNM8151, FKM8151, GNM8151, HNM8151, TRM8151 and WNM8151. || Electronic infusion pumps are indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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