Events

Retiro De Equipo (Recall) de Device Recall Terumo Advanced Perfusion System 1

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 Terumo Cardiovascular Systems Corporation.

¿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
    58547
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2736-2011
  • Fecha de inicio del evento
    2011-03-31
  • Fecha de publicación del evento
    2011-07-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99576
  • 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 firm has received multiple reports of the lower roller pump tube clamp mechanism failing to function in a small population of devices, making it difficult to remove or insert the tubing. if the failure occurs, the clamp dial will no longer be able to control opening/closing of the tube clamp mechanism.
  • Acción
    Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE CORRECTION letter to all affected customers dated March 21, 2011. The letter identified the product, the problem and the action needed to be taken by the customer. An additional URGENT MEDICAL DEVICE RECALL correction notification and cover letter was sent to all consignees on XX/XX/XX to explain the reason for the expansion of the recall and will provide an update to the timing of implementation of the field correction. Expansion now includes devices manufactured between 2006 and March 2012. The correction strategy is to issue the customers a letter and addendum to the Operator's Manual that specifies what the user should do in the event of a tube clamp failure for any reason. The letter states that the firm is still investigating the issue and the correction. The letter states that in the coming months when a resolution is identified, consignees may be contacted to make arrangements for a upgrade to the system. There is no specific timeline for the correction to be made. If you have any further questions, please call a Terumo CVS Customer Service at 1-800-521-2818. Customer Service hours Monday - Friday, 8 Am - 6 Pm EST.

Device

Device Recall Terumo Advanced Perfusion System 1
  • Modelo / Serial
    serial numbers 006-1384.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) and the countries of Argentina, Australia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Japan, Jordan, Korea, Kuwait, Malaysia, Mexico, Pakistan, Republic of Georgia, Russia, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, The Phillipines, Turkey, United Arab Emirates and Vietnam.
  • Descripción del producto
    System 1 Base 220V, Catalog 801764, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI || The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Dirección del fabricante
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    USFDA