Events

Retiro De Equipo (Recall) de Device Recall Intersept Custom Tubing Pack

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
    37079
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0583-2007
  • Fecha de inicio del evento
    2007-01-02
  • Fecha de publicación del evento
    2007-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49877
  • 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
    custom tubing pack for cardiopulmonary bypass - Product Code DWE
  • Causa
    One lot of custom perfusion sets, catalog 2t10r1 was incorrectly assembled. the one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.
  • Acción
    There was only one customer. The customer was sent a letter on December 29, 2006, requesting that the impacted product be disposed of or returned to Medtronic for disposal.

Device

Device Recall Intersept Custom Tubing Pack
  • Modelo / Serial
    Lot 5666215
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Illinois
  • Descripción del producto
    Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuum relief valve assembled in one end. Tubing is used in the vent roller heads of the heart lung machine. This tubing is connected to the cannula in the patient in order to divert blood to the circuit when the patient is on bypass.
  • 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