Events

Retiro De Equipo (Recall) de Device Recall Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540

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
    79058
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0645-2018
  • Fecha de inicio del evento
    2018-01-16
  • 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=161254
  • 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
    Reservoir, blood, cardiopulmonary bypass - Product Code DTN
  • Causa
    Possible sterile barrier breach in the pouch of affinity nt cardiotomy venous reservoir stand alone uncoated and affinity nt cardiotomy venous reservoir stand alone trillium coated products.
  • Acción
    Medtronic sent an Urgent Medical Device Recall Letter dated January 16, 2018. Customer Actions: Please review your inventory for product affected by this issue. 1.) Immediately identify and quarantine all unused, non-expired, affected product in your inventory. 2.) Return all unused, affected product in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570 Option 4, or accessing My Orders and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of affected product as necessary. 3.) Complete the enclosed Customer Confirmation Certificate and scan and email to RS.CFQFCA@medtronic.com. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. For further questions, please call (763) 526-2494.

Device

Device Recall Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540
  • Modelo / Serial
    All lots
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution and to the countries of : Australia, Canada, Colombia, Denmark, Germany, Guyana, Israel, Italy, Japan, Netherlands, Norway, Saudi Arabia and United Kingdom.
  • Descripción del producto
    Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 || The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.
  • 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