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
    57416
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0883-2011
  • Fecha de inicio del evento
    2010-12-02
  • Fecha de publicación del evento
    2011-01-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96152
  • 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 identified that a component within the system 1 abd and occluder modules that may malfunction. the air bubble detector module (abd) is used with an air sensor to detect gross air bubbles in the perfusion circuit. the occluder module is used with the occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line. the firm identified a fai.
  • Acción
    Terumo Cardiovascular Systems Corporation issued an URGENT MEDICAL DEVICE CORRECTION letter dated 12/2/2010 to the Director of Cardiac Operating Room Services or Operating Room Nurse Manager. The letter identified the product, the problem, and the action to be taken. The letter stated the firm will replace all modules in the affected population, and that a representative would contact the consignee regarding the replacement schedule. Customers were to review the Medical Device Correction. Assure that all user were aware of the notice. Confirm receipt of the communication by faxing the attached Customer Response Form to the fax number indicated on the form. For questions regarding this recall call 1-800-521-2818.

Device

Device Recall Terumo Advanced Perfusion System 1
  • Modelo / Serial
    00632-00635, 00638, 00642-00711, 00713-00715, 00717-00741, 00752-00813, 00815-00821, 00823-00864, 00867, 00869-00874.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US, Austrailia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Guatamala, Hong Kong, Indonesia, Japan, Korea, Malaysia, Mexico, Phillipines, Saudi Arabia, Singapore, Taiwan, Thailand, United Arab Emirates, and Vietnam
  • Descripción del producto
    Occluder module, catalog 803480, Terumo Cardiovascular System Corp, Ann Arbor, MI. || The occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line.
  • 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