Events

Retiro De Equipo (Recall) de Device Recall 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
    62684
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2230-2012
  • Fecha de inicio del evento
    2012-07-26
  • Fecha de publicación del evento
    2012-08-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111350
  • 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
    Terumo cardiovascular systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the terumo advanced perfusion system 1. some reports stated that the odor of smoke was as associated with the failures. the malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the modu.
  • Acción
    Terumo sent an URGENT MEDICAL DEVICE Recall letter dated July 24, 2012 to all affected customers. The letter identified the affected product, reason for correction, potential hazard and actions to be taken. The letter stated that Terumo CVS will replace all affected modules. Customers were informed that a Terumo VS Representative will contact the user to schedule a service call for the replacement upon receipt of the Response Form attached. For questions contact Terumo CVS Customer Service at 800-521-2818.

Device

Device Recall System 1
  • Modelo / Serial
    catalog number: 802113 and serial numbers: 00007-00036, 00038-00045, 00047-00064, 00066-00077, 00080-00121, 00123-00214,00216-00283, 00285-00363, 00366-00498, 00500-00548, and 00550-00597.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV and the countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Germany, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Singapore, South Africa, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam
  • Descripción del producto
    Serial interface module RS-232 || Product Usage: || The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data Perfusion oftware and the system. The data collected and exported by the data transfer module includes physiological data and device events to record the progress and events during a procedure.
  • 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