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
    65380
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1978-2013
  • Fecha de inicio del evento
    2013-07-26
  • Fecha de publicación del evento
    2013-08-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119873
  • 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
    Tcvs is taking action to update the operators manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. in the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started by disconnecting the pressure transducer from the system.
  • Acción
    Terumo sent an Urgent Medical Device Recall notification letter dated July 26, 2013 to all affected customers. The letter identified the affected product, reason for correction, potential hazards of the recall issue, the correction to be implemented, and customer instructions for replying to the recall notification. Terumo CVS is providing an addendum to be placed in the Operator's Manual at the beginning of Chapter 7, Modules. Questions or concerns are directed to Terumo CVS Customer Service at 1-800-521-2818, Recall Fax 1-877-275-6860. Customer Service hours are Monday to Friday 8am-6pm ET.

Device

Device Recall Terumo Advanced PErfusion System 1
  • Modelo / Serial
    Catalog number: 801764
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of :AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MSMT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and countries of AUSTRALIA, UNITED ARAB EMIRATES (UAE),Hong Kong,Indonesia, Singapore, Taiwan, Thailand,Philippines, CHILE,Malaysia, South Korea, BELGIUM,Japan,Mexico,CANADA
  • Descripción del producto
    220/240V AC, Advanced Perfusion System 1 || Product Usage: || The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

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