Events

Retiro De Equipo (Recall) de Device Recall Outlook ES Safety Infusion System

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 B Braun Medical, Inc.

¿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
    59847
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0007-2012
  • Fecha de inicio del evento
    2010-07-20
  • Fecha de publicación del evento
    2011-10-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103856
  • 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 outlook es dose guard care area can inadvertently be exited when the pump enters the kvo (keep vein open) state. the same condition can occur when a sequence of hold-hold key strokes are performed on the pump key panel.
  • Acción
    The firm, B. Braun Medical Inc., sent an "URGENT: FIELD CORRECTION" letter dated September 8, 2011 to its customers. The letter described the product, problem and actions to be taken. The firm informed the customers that a B. Braun representative will be contact ing them to schedule a field software upgrade of the affected pumps. The customers were instructed to complete and return the FIELD CORRECTION INFORMATION FORM via mail using the enclosed envelop and contact B. Braun Customer Service for shipping instructions at 1-800-627-7867 if product is to be returned. Should you require any additional information, please do not hesitate to contact B. Braun Medical Inc., Technical Product Support at 1-800-627-7867 (800-627-PUMP).

Device

Device Recall Outlook ES Safety Infusion System
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AR, CA, FL, GA, IA, IL, KS, KY, LA, MA, MI, MO, NC, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and WV; and country of: Canada.
  • Descripción del producto
    Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES || B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 || The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.
  • Manufacturer
    B Braun Medical, Inc

Manufacturer

B Braun Medical, Inc
  • Dirección del fabricante
    B Braun Medical, Inc, 1601 Wallace Dr Ste 150, Carrollton TX 75006-6690
  • Empresa matriz del fabricante (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA