Events

Retiro De Equipo (Recall) de 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
    59848
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0051-2012
  • Fecha de inicio del evento
    2011-09-07
  • Fecha de publicación del evento
    2011-10-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103860
  • 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
    B braun outlook es safety infusion system "run" light emitting diodes (leds) pumps stop infusing and a backup alarm sounds, but the "run" leds advance as if the pumps were infusing.
  • Acción
    B. Braun Medical, Inc. sent an "URGENT: FIELD CORRECTION" letter dated September 7, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. A firm representative will contact all affected customers in order to schedule the field correction. The correction consists of revising the Door and Main Processor software, inspecting the main board, and replacing the board, if warranted. A Field Correction Information Form was included in the letter for customers to complete and return. Contact Technical Product Support at 1-800-627-7867 for questions regarding this notice.

Device

Outlook ES Safety Infusion System
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES, 621-400ES, 621-400ESR. || To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
  • 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