Retiro De Equipo (Recall) de Device Recall Baxter PCA II Syringe Infusion Pump

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
    34244
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0553-06
  • Fecha de inicio del evento
    2005-12-21
  • Fecha de publicación del evento
    2006-04-26
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2008-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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, Pca - Product Code MEA
  • Causa
    Delivery of unrequested pca doses of medication due to damaged pca cords, partial sticking of pca button, and fluid ingress into the pump or pca button.
  • Acción
    Baxter sent Urgent Device Correction letters dated 12/21/05 to the direct accounts on the same date via first class mail. The letters informed the accounts of the potential for unrequested PCA doses due to an electrical short in the PCA circuit simulating repeated pressing of the PCA button. The unrequested bolus doses will not exceed the programmed prescription limits. The letter listed three conditions identified that can produce an electrical short in the PCA circuit and simulate repeated pressing of the PCA button: * Damaged PCA cord or button, * Partial sticking of the PCA button, and * Fluid ingress into the pump or PCA button. Information was provided to reduce the potential for these conditions from occurring during use of the pumps. Customers were asked to ensure that prior to or after each use the PCA cord is intact and has no cuts or missing insulation, and that the pump connector and the button are securely attached to the cord. They were also asked to immediately take the pump and PCA cord out of service for repair if the pump displays 'Release the PCA Button' and the PCA button is not being intentionally pressed, as there may be a mechanical or electronic fault in the PCA button. They were also asked two avoid getting liquids inside the pump as permanent damage may result. Baxter recommended that the institutions implement a regular preventative maintenance program and periodic replacement of the PCA cords based on their own specific usage patterns. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter sent a follow-up recall letter to the accounts on 6/21/06, providing them with an Operator's Manual Addendum for the AP II Infusion Pump and the PCA II Infusion Pump, with the warnings to ensure that prior to or after each use that the PCA cord is intact and has no cuts or missing insulation, and that the pump connector and the button are securely attached to the cord; to avoid getting liquids inside the pump; and

Device

  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide including Puerto Rico, and internationally to Canada, Chile, China, Hong Kong, Korea, Kuwait, Malaysia, Taiwan and Saudi Arabia
  • Descripción del producto
    Baxter PCA II Syringe Infusion Pump, product codes 2L3104 and 2L3104R; Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer

Manufacturer

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