Events

Retiro De Equipo (Recall) de Sarns Centrifugal System

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
    62059
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0051-2013
  • Fecha de publicación del evento
    2012-10-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109800
  • 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, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
  • Causa
    Terumo cardiovascular systems (terumo cvs) received one report of loss of power to the control module and subsequently the drive motor for the sarns centrifugal system during cardiopulmonary bypass.
  • Acción
    TERUMO sent an Urgent Medical Device Recall dated April 13, 2012, to all affected consignees. An Addendum was sent on September 25, 2012. All US Consignees will receive a Safety Advisory and an update to the Operator's Manual via Federal Express to inform them of the reported malfunction and potential hazards and to raise awareness of the benefits of using a retrograde valve and the importance of back-up system availability. TERUMO will include a customer response form and follow up with all affected users to obtain a response to the recall. For questions customers should call 1-800-521-2818. For questions regarding this recall call 734-741-6173.

Device

Sarns Centrifugal System
  • Modelo / Serial
    Catalog number: 6379 and serial numbers: 942,1003-1006,1034,1039,1051,1056,1087,1914,3030,4019,4344, 5009,5012,5013,5030,5048,5059, 5062, 5080, 5096, 5111, 5112, 5122, 5140, 5713, 6003, 6005, 6023, 6024, 6027, 6033, 6034, 6054, 6055, 6060, 6066, 6068, 6069, 6073, 6079, 6081, 6082, 6086, 6089, 6090-6092, 6097, 6107, 6109, 6112, 6119, 6126-6128, 6236, 6379, 7000-7785, and R7051.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Bangladesh, Seoul Korea, Chile, Brazil, Venesuela, Thailand, Mexico, India, Taiwan, Canada, Dominican Republic, Guatemala, Ecuador, Germany, Republic of Georgia, Hong Kong, Japan, United Arab Emirates (UAE), Japan, Belgium, Phillipines, Singapore, and South Africa.
  • Descripción del producto
    Sarns Centrifugal System Control module, 100/115V || The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
  • 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