Events

Retiro De Equipo (Recall) de Dialog Hemodialysis machine: Dialog A 1 Blood Pump 120V

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
    73744
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1536-2016
  • Fecha de inicio del evento
    2016-04-01
  • Fecha de publicación del evento
    2016-05-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144896
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Causa
    Potential leakage of conductivity sensors of the dialog dialysis machines.
  • Acción
    B. Braun mailed an Urgent Medical Device Correction notice to affected customers informing them of the Dialog+Hemodialysis System due to the potential for Bicarbonate and End conductivity cells (3456102A and 3456103A respectively) to exhibit cracks. Notice provided customers with actions for Qualified Service Technicians, Clinical Personnel Administering Dialysis treatment and adverse event reporting. All Dialog+Hemodialysis machines will be inspected at the customer's site by the customer Biomed, who has been trained and qualified by B. Braun Avitum. The inspection of each machine will be performed in accordance to a Field Service Information (FSI). Customers with questions were instructed to contact the Technical Support Team at 800-621-0445 or the Customers Service Team at 800-848-2066. For questions regarding this recall call 610-997-4717.

Device

Dialog Hemodialysis machine: Dialog A 1 Blood Pump 120V
  • Modelo / Serial
    Item # 3456103A
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX, NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI
  • Descripción del producto
    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A || The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
  • Manufacturer
    B Braun Medical Inc

Manufacturer

B Braun Medical Inc
  • Dirección del fabricante
    B Braun Medical Inc, 824 12th Ave, Bethlehem PA 18018-3524
  • Empresa matriz del fabricante (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA