Events

Retiro De Equipo (Recall) de Device Recall Prismaflex

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 Gambro Renal Products, Incorporated.

¿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
    58208
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1901-2011
  • Fecha de inicio del evento
    2011-03-14
  • Fecha de publicación del evento
    2011-04-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98675
  • 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
    Prismaflex touch screen may become unresponsive during continuous renal replacement therapy procedure.
  • Acción
    The firm, GAMBRO Renal Products, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated March 14, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were provided with response procedures to use if the frozen screen problem occurs while using the product. The customers were instructed to closely monitor the return line for potential air and/or clots in the circuit; review the instructions provided in the attached copy of Chapter 5: Troubleshooting, "Softkeys won't work." of the Prismaflex Operators Manual in conjunction with the attached Troubleshooting Checklist; be aware if performing Manual Termination with Blood Return, air detection is not provided, and complete and return the Customer Reply Form via fax to: Regulatory Affairs at 1-866-447-4471 or 303-222-6916, or by email to: GRPRegulatory.Affairs@us.gambro.com. If you have any questions or concerns, please contact for Clinical questions: ICON 800-554-1312 (available 24/7) or your local Gambro Representative; for Technical questions: Gambro Customer Support 800-525-2623, option 2 (Available 6:00am to 5:30pm MT, Monday thru Friday).

Device

Device Recall Prismaflex
  • Modelo / Serial
    All units with Version 3.20 software.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    Prismaflex System, Catalog Number 107493, || Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload.
  • Manufacturer
    Gambro Renal Products, Incorporated

Manufacturer

Gambro Renal Products, Incorporated
  • Dirección del fabricante
    Gambro Renal Products, Incorporated, 14143 Denver West Pkwy, Lakewood CO 80401-3266
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA