Events

Retiro De Equipo (Recall) de 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
    55911
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2481-2010
  • Fecha de inicio del evento
    2010-09-10
  • Fecha de publicación del evento
    2010-09-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94169
  • 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 design document states that the oxygen sensor would operate for 300,000 hours but the supplier of the oxygen sensor indicated that it has a 100,000 hour warranty. the oxygen sensor is a consumable part that slowly depletes over time. at the end of its service life, a depleted oxygen sensor results in a gas system calibration failure or a message to the user prompting service for the gas syst.
  • Acción
    Terumo issued a URGENT MEDICAL DEVICE CORRECTION letter dated September 10, 2010, identifying the affected product, the issue prompting the correction, and what actions are to be taken by the customer. The firm included the addendum to the operators manual with the recall letter. The addendum recommended replacement of the oxygen sensor every six months instead of every 12 months. The addendum provided additional user instructions in the event of a calibration failure of the sensor. Customers are to complete and return the enclosed Customer Response Form to the firm. Terumo CVS Customer Service can be contacted by 1-800-521-2818 Monday through Friday, 8 AM  6 PM EST.

Device

Terumo Advanced Perfusion System 1
  • Modelo / Serial
    Serial numbers 0001-1315.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA, including the states of AL,AZ, CA, CO, CT, DC, FL, GA, HI, IA, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, and WV, and the countries of Canada, Indonesia, China, Chile, UAE, Japan, Singapore, UK, Malaysia, Taiwan, Belgium, Korea, Phiippines and Thailand.
  • Descripción del producto
    Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base, Terumo Cardiovascular System, Ann Arbor MI. (This product is not distributed in the US)
  • 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