Events

Retiro De Equipo (Recall) de Device Recall Fresenius 2008 Series Hemodialysis Delivery Systems

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 Fresenius Medical Care Renal Therapies Group, LLC.

¿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
    73487
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1325-2016
  • Fecha de inicio del evento
    2016-03-10
  • Fecha de publicación del evento
    2016-04-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144284
  • 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
    Added warning statement: fresenius 2008 series hemodialysis machines false blood leak alarm when dialyzing patients treated with hydroxocobalamin (or any form of vitamin b-12).
  • Acción
    Fresenius Medical Care issued an Urgent Medical Device Alert dated March 10, 2016, to all affected consignees. Consignees were instructed to place notification and Warning Addendum with their 2008¿ Series Hemodialysis Machine Operators Manual. A reply form was included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. Further information or support concerning this issue, customers were instructed to contact Fresenius Technical Services at 800-227-2572.

Device

Device Recall Fresenius 2008 Series Hemodialysis Delivery Systems
  • Modelo / Serial
    Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: || Models: || Fresenius 2008K and 2008K2 Dialysate Delivery System || Fresenius 2008K@home Hemodialysis Machine with bibag System || 2008T Hemodialysis Machine || The Fresenius 2008¿ Series Machines are indicated for acute and chronic dialysis therapy
  • Manufacturer
    Fresenius Medical Care Renal Therapies Group, LLC

Manufacturer

Fresenius Medical Care Renal Therapies Group, LLC
  • Dirección del fabricante
    Fresenius Medical Care Renal Therapies Group, LLC, 920 Winter St, Waltham MA 02451-1521
  • Empresa matriz del fabricante (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA