Events

Retiro De Equipo (Recall) de Device Recall Baxter FloGard 6201 Volumetric 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
    57334
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0933-2011
  • Fecha de inicio del evento
    2010-11-17
  • Fecha de publicación del evento
    2011-01-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95890
  • 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
    The flogard infusion pump was released from service without having the current leakage test performed. this could lead to the patient/user to receive an electrical shock.
  • Acción
    The firm, Baxter, telephoned the one customer on November 17, 2010, informing them that electrical safety testing was not performed on their FloGard pump serial number 11091330FA during the last service. Since the test was not conducted on the pump, the device may not function as designed and could lead to a hazard of electrical shock. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter advised the customer that a Baxter Field Service Engineer would be sent to their facility to perform electrical safety testing or alternatively, the customer may choose to send the pump to Baxter for testing. If you have any questions regarding this information, please contact Vice President, Quality, GIS at 847-270-5507.

Device

Device Recall Baxter FloGard 6201 Volumetric Infusion Pump
  • Modelo / Serial
    product code 2M8063, serial number 11091330FA
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: WA only
  • Descripción del producto
    Baxter FloGard 6201 Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product code 2M8063 || For delivery of intravenous solutions, drug solutions, enteral feedings and blood.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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