Events

Retiro De Equipo (Recall) de Device Recall Maquet Cardiopulmonary Bypass Custom Tubing kit

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 Datascope 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
    80086
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2106-2018
  • Fecha de inicio del evento
    2016-03-11
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164534
  • 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
    Tubing, pump, cardiopulmonary bypass - Product Code DWE
  • Causa
    There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of h/s disconnect at cuvette.
  • Acción
    Urgent Safety Alert notifications were sent to customers on 3/11/16. The notices included the following instructions for customers: Please examine your inventory immediately to determine if you have the lot/batch numbers listed. If so, please following the recommended actions outlined in the attached Terumo Cardiovascular Systems Urgent Safety Alert. URGENT: Please complete attached Customer Response Form on page 3, to acknowledge that you have received the Terumo Cardiovascular Systems Urgent Safety Alert. Please fax the completed Customer Response Form to 1-973-396-3607 or send via email to fieldactions@maquet.com.

Device

Device Recall Maquet Cardiopulmonary Bypass Custom Tubing kit
  • Modelo / Serial
    Batch Number 3000018640, UDI Code 10607567205373;  Batch Number 3000020516, UDI Code 10607567205373
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The products were distributed to the following US states: AL, OR, and TX.
  • Descripción del producto
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • Dirección del fabricante
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-3206
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA