Retiro De Equipo (Recall) de Device Recall MiniInfuser Model 150XL 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • 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 - Product Code FRN
  • Causa
    Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the mini-infuser will not operate. the reason being that the mini-infuser battery spring has a flat contact that measures .53 inches ¿.01 inches on the inner diameter of the spring coil. the iec 60086-2 and ansi 08 standards specify a minimum.
  • Acción
    Baxter sent a Safety Alert letter on January 11, 2011 for the InfusO.R. Pump. Baxter expanded the scope of the recall to include the Mini-Infusers System and sent an Urgent Device Correction letter dated March 4, 2011, via First Class mail to all affected customers. The letters informed the customers that the Mini-Infusers use the same size battery and incorporate the same battery contact interface as the InfusOR pump, and that the same feature that inhibits electrical contact in over-the counter Energizer C size batteries may also be incorporated by other battery manufacturers. The customers were requested to verify that the InfusOR and Mini-Infuser will power-on before use; if the device does not power on, replace the batteries with a different brand of size C batteries and verify that the device will power-on before use; and to place a copy of the letter with each operator's manual for the InfusOR and Mini-Infuser System for future reference. For Technical questions call Baxter Global Technical Services at 1-800-843-7867. For question regarding this communication contact the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.


  • Modelo / Serial
    product codes 2M8170 and 2M8170R, all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    45,865 units
  • Descripción del producto
    Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; || Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.
  • Manufacturer


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