Events

Retiro De Equipo (Recall) de Device Recall Medtronic Performer CPB

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 Medtronic Perfusion Systems.

¿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
    38154
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1090-2007
  • Fecha de inicio del evento
    2007-06-04
  • Fecha de publicación del evento
    2007-07-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53035
  • 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
    Electromechanical extracorporeal support device - Product Code DTQ
  • Causa
    Device failure requiring use of back up systems (malfunctioning printed circuit board (pcb)).
  • Acción
    There are two separate letters dated June 4, 2007 for the customers, based on the configuration of the unit being inspected/updated in the field. These letters explains the situaiton and informs the customers that Medtronic will be visiting each customer site to inspect/update the units. Medtronic Service Technicians will complete a Field Action Certicate acknowledging the successful completion of the update.

Device

Device Recall Medtronic Performer CPB
  • Modelo / Serial
    Model Number: R5100052-Serial Numbers: 115, 118, 124, 138, 140, 141, 148, 113, 116, 117, 122,127, 130, 137 103, 109, 132, 135, 105, 107, 108, 110, 131, 133.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA including states of PA, ND, MN, CA, AL, CO, MI, NY, AZ, and OH and countries of Sweden, Iceland, Latvia, Germany, Italy, Austria, Belgium, and France.
  • Descripción del producto
    Medtronic Performer CPB-Universal R2100375. || Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Manufactured by: RanD S.r.l 41036 Mendolla (MO) Italy. Distributed exclusively by Medtronic, Inc.
  • Manufacturer
    Medtronic Perfusion Systems

Manufacturer

Medtronic Perfusion Systems
  • Dirección del fabricante
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA