Events

Retiro De Equipo (Recall) de HyperHypothermia 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 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
    60721
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0970-2012
  • Fecha de inicio del evento
    2011-10-27
  • Fecha de publicación del evento
    2012-02-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106308
  • 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
    System, thermal regulating - Product Code DWJ
  • Causa
    The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of aids and cancer patients, were not appropriately cleared by the fda prior to distribution.
  • Acción
    CSZ sent an "URGENT: FIELD ACTION NOTICE" letter dated January 20, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to become familiar with the amended manual page and to get approvals from the Institutional Review Board before further use of the device. Additionally, a response form was enclosed with the letter for customers to complete and return via fax to (513)772-9119. Contact CSZ Service Department at 1-800-989-7373 for questions regarding this notice.

Device

HyperHypothermia System
  • Modelo / Serial
    The recalled Hemotherm Heater/Cooler devices are identified with the following Serial Numbers: 862-8586M, 882-9143M, 882-9163M, 914-9837M, 952-10505M, 973-10918M, 992-11343M, 002-11540M, 003-11585M, 003-11586M, 003-11592M, 003-11600M, 004-11830M, 004-11631M, 014-11807M, 0311-12041M, 042-12250M, 071-12654M, 071-12655M, 073-12117M, 972-10872M, 062-12536M, and 963-10737M.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution-including the District of Columbia and states of CA, GA, MA, MD, MI, NJ, NY, OH, and UT.
  • Descripción del producto
    Hemotherm 48¿C Dual Reservoir Heater/Cooler System, Model Number: 400 and Model Number: 400MR. The 48 o ( Degree) C Hemotherm Dual Reservoir Heater/Cooler I provides a flow of temperature-controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm/cool the fluid that enters and exits a heat exchanger. The conductive heat/cool transfer is accomplished through any type of blood oxygenator/heat exchanger unit. The operator of the unit regulates the desired fluid temperature. Frequent observation of the actual blood/fluid temperature and body temperature is required. The Hemotherm does not contact the patient of the fluids; the water being circulated by the Hemotherm is separated from the fluid by the heat exchanger. To active temperatures above 42 Degrees C, the user must follow explicit instructions in to the owner's manual in order to activate the higher setting. Without following the explicit instructions, the device can only operate within the normal maximum temperature range of: 42 degrees C. The Hemotherm can be used with adult and pediatric patients for extracorporeal circulation of the patient's limb, entire body, or a chemo medication lavage of the abdominal area. || The Hemotherm 48¿C device system is used to lower/raise the blood/fluid temperature and/or maintain blood/fluid temperature, as required, through conductive heat transfer. The conductive heat transfer is accomplished through any type of Blood Oxygenator/Heat Exchanger unit. This device is intended to hyperthermic treatment of AIDS and cancer patients and associated research. The device can be set to reach an upper temperature of: 48¿C .
  • 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 45241-1528
  • Empresa matriz del fabricante (2017)
    Gentherm, Inc.
  • Source
    USFDA