Events

Retiro De Equipo (Recall) de Baxter Auto Syringe AS50 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
    49443
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0152-2009
  • Fecha de inicio del evento
    2008-09-05
  • Fecha de publicación del evento
    2008-10-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73334
  • 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
    Non-conforming electrostatic discharge (esd) grounding squares may cause the pump to be susceptible to shorting-out of circuitry, resulting in a loss of audio, and/or interruption of therapy.
  • Acción
    Urgent Product Recall letters dated 9/5/08 were sent on the same date via first class mail to the direct accounts, to the attention of the Director of Biomedical Engineering and Facility Risk Manager. If the account had device(s) that had been serviced by Baxter with a part affected by this action, a serial number list of the affected device(s) was provided with the notification. Customers were instructed to remove the affected device(s)/spare parts from service and contact Baxter to arrange for their return and repair. Alternatively, if removal of the device is not a viable alternative for the customer and they wish to perform self-service, the customers will also be provided with a Service Bulletin to provide instruction on replacement of the rear case assembly.

Device

Baxter Auto Syringe AS50 Infusion Pump
  • Modelo / Serial
    Product code 1M8550 serviced or repaired with part numbers AAS5001530RP, AAS5001531RP or A069160000RP between 11/1/07 and 7/29/08.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- USA including Puerto Rico, and countries of Canada and Korea.
  • Descripción del producto
    Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A. || Indicated for infusion via intravenous, intra-arterial, epidural or subcutaneous routes of administration.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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