Events

Retiro De Equipo (Recall) de Baxter 6060E & Sabratek 6060 Epidural 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
    33032
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1592-05
  • Fecha de inicio del evento
    2005-08-17
  • Fecha de publicación del evento
    2005-09-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41229
  • 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
    Potential overinfusion in the auto-ramp mode with software versions 3.00 or higher.
  • Acción
    Baxter sent the 8/17/05 Urgent Product Recall letter to all Baxter 6060E Infusion Pump customers to inform them of a software anomaly present in software versions 3.00 and higher, which allows the pump to overinfuse in the Auto-Ramp mode. The end users were also informed that these epidural pumps, identified by the yellow housing, can no longer be supported due to a lack of availability of spare parts and Baxter is unable to replace the software with an alternate version. As a result, Baxter requested the accounts to remove the pumps from service and return them to Baxter. The accounts were requested to call Baxter''s Medication Delivery Services at 1-800-843-7867 to arrange for the return of the units and replacement with 6060 Multi-Therapy Infusion Pumps.

Device

Baxter 6060E & Sabratek 6060 Epidural Infusion Pumps
  • Modelo / Serial
    product codes 2L9351, 2L9351P, 2L9351R, 606000-40E and 606000-40EL: all serial numbers
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide including Puerto Rico, and intenationally to Canada, China, Belgium, Hong Kong and Saudi Arabia
  • Descripción del producto
    Epidural Infusion Pumps sold under the following labels; || a) Baxter 6060E Epidural Infusion Pump, product code 2L9351, 2L9351P and 2L9351R; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore || b) Sabratek 6060 Epidural Pain Management Pump, product codes 606000-40E and 606000-40EL; Manufactured by Sabratek Corp., Skokie, IL 60076, which was purchased by Baxter Healthcare Corp., Deerfield, IL in January 2000.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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