Events

Retiro De Equipo (Recall) de Device Recall Cardiopulmonary bypass temperature controllers

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 Cincinnati Sub-Zero Products Inc.

¿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
    58971
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2721-2011
  • Fecha de inicio del evento
    2011-05-02
  • Fecha de publicación del evento
    2011-07-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100747
  • 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
    Cardiovascular Thermal Regulating System - Product Code DWJ
  • Causa
    The probe jack contacts (terminals) on certain of the firm's ecmo heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. if this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use.
  • Acción
    Cincinnati Sub-Zero Products Inc issued an "Urgeant Medical Device Field Action" letter on May 2, 2011 to all affected customers. The letter includes; description of product and problem, affected lots and instructs customers to discontinue its use. The product is to be returned to the Service Department for an update and the customer is instructed to complete and mail Field Action Form. For additional contact the firm at 1-800-989-7373 or (513) 772-8810.

Device

Device Recall Cardiopulmonary bypass temperature controllers
  • Modelo / Serial
    Model: 333W Part Number: 86135 (115V), 86136 (230V) and 86138 (240V) Serial Number: 942-E2979 through 031-E5150
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution and countries of The Netherlands, Kuwait, India, Saudi Arabia, Taiwan and Australia. (USA) Nationwide including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MIN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, WA, and WI.
  • Descripción del producto
    ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. || This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • Dirección del fabricante
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241
  • Empresa matriz del fabricante (2017)
    Gentherm, Inc.
  • Source
    USFDA