Events

Retiro De Equipo (Recall) de Infusion Pumps & Refill Kits

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 Codman & Shurtleff, 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
    65821
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2296-2013
  • Fecha de inicio del evento
    2013-08-13
  • Fecha de publicación del evento
    2013-09-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121575
  • 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, implanted, programmable - Product Code LKK
  • Causa
    Drug flow rates exceeding programmed flow rates.
  • Acción
    Codman & Shurtleff, Inc. sent a Medical Device Field Safety Notice letter dated August 13, 2013 to US Consignees via FedEx overnight delivery and International Consignees were notified of the recall via email. The letter identifed the affected products, potential clinical impact, and updated IFU pump filling warning. The letter informed consignees that the Instructions for Use (IFU) and product training materials had been updated by adding a warning statement about potential over infusion if air gets inside the pump reservoir and additional clarifications to reinforce the proper filling technique. Consignees are asked to complete the Field Safety Notice Acknowledgement Form and return it to your local Codman Neuro Sales Representative or fax to: 508-977-6665. Consignees are asked to contact your Codman Neuro representative if they have questions, or contact Codman Neuro Clinical Support at 1-800-660-2660. Please report any malfunction or adverse event related to this device to 1-866-491-0974, Option 2.

Device

Infusion Pumps & Refill Kits
  • Modelo / Serial
    OUS: Per recall strategy
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.
  • Descripción del producto
    MedStream Programmable Pump; 20ml Pump EMEA 91-4200 || Product Usage: || The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.
  • Manufacturer
    Codman & Shurtleff, Inc.

Manufacturer

Codman & Shurtleff, Inc.
  • Dirección del fabricante
    Codman & Shurtleff, Inc., 325 Paramount Drive, Raynham MA 02767
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA