Retiro De Equipo (Recall) de Device Recall S5 Double Roller Pump 85

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 Sorin Group Deutschland GmbH.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Causa
    The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft.
  • Acción
    Sorin Group sent an Urgent Field Safety Notice dated February 23, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: Before each use of the device during the set-up procedure, rotate all pump speed control knobs back and forth to check for smooth operation. If abnormal friction or any binding is detected, please do not use the system until it is repaired. If an affected product is currently in use with a patient and an increase of friction is detected please prepare for a replacement pump. Please complete and return the attached Confirmation Form by fax to 303-467-6502. Customers were instructed to ensure that the Urgent Field Safety Notice is distributed to all personnel in their organization who need to be aware of the notice. If the product was transferred to a third party, customers were asked to share the information with them as well as Sorin Group USA Customer Service at 1-800-850-2623. For questions regarding this Urgent Field Safety Notice, contact Sorin Group USA Customers Service at 1-800-650-2623. All affected customers and distributors were notified of the Field Correction by certified mail beginning on February 23, 2012. They will be contacted by Sorin Service Group to arrange an appointment to replace affected shaft encoders on site.


  • Modelo / Serial
    10E51342 to 10E51597
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    S5 Double Roller Pump 85 || The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
  • Manufacturer


  • Dirección del fabricante
    Sorin Group Deutschland GmbH, Lindberghstrasse 25, Munchen Germany
  • Empresa matriz del fabricante (2017)
  • Source