Events

Retiro De Equipo (Recall) de Terumo Backplate Replacement CXFVR 1500 Holder

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
    63225
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0071-2013
  • Fecha de inicio del evento
    2009-10-02
  • Fecha de publicación del evento
    2012-10-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113066
  • 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
    Accessory equipment, cardiopulmonary bypass - Product Code KRI
  • Causa
    Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. the devices were manufactured and configured with two 3/8 inch and one ¿ inch connector supports instead of one 3/8 inch and two ¿ inch connector supports (see location of supports as # 7 and # 8 on backplate attachment). the backplates were manufactured as described in manufacturing instructions a.
  • Acción
    The firm, Terumo, interviewed the Sr. Product Manager from the Marketing Department of the company on August 29, 2012. The interview included the description of the product, problem and action taken. Replacement connectors were provided to users and all units were corrected. If you have any questions, call 734-663-4145 or Manager, Regulatory Affairs at 734-741-5576.

Device

Terumo Backplate Replacement CXFVR 1500 Holder
  • Modelo / Serial
    No lot/serial number; Catalog number: PN 816280
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: CA, MI, NC, NJ, PA, and WI;and country of: EUROPE.
  • Descripción del producto
    Terumo Backplate Replacement CXFVR 1500 Holder || The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines that enter and exit the venous bag. The Backplate/Holder is designed to allow the user to move the port support location to accommodate different tubing circuit designs to permit mounting flexibility.
  • 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