Events

Retiro De Equipo (Recall) de Medtronic Surgical Membrane Oxygenator

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 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
    50161
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0975-2009
  • Fecha de inicio del evento
    2008-10-17
  • Fecha de publicación del evento
    2009-02-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74883
  • 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
    Surgical Membrane Oxygenator - Product Code DTZ
  • Causa
    Medtronic has identified an issue with the labeling of the i-4500 silicone oxygenators (p/n 61399402655). lot numbers of this oxygenator manufactured between august 2007 and september 2008 have an incorrect "recommended maximum blood flow range" on the label. the label on the device states a range of 5.0 - 8.5 l/min but should state a range of 5.0 - 6.5 l/min. these oxygenators are acceptable t.
  • Acción
    A consignee letter " Urgent Medical Deive Notice" dated October 17, 2008 was sent to the impacted customers on October 17, 2008. The letter described the issue and product and confirmed the correct maximum internal flow of 6.5 L/min for the I-4500 Silicone Oxygenators. The letter states the product will not be removed from the field. Customers were instructed to complete the" Medtronic Product Notification Certificate (FCA 0903)" acknowledging receipt of the information and fax the completed certificate to 763-391-9603. Please direct questions about the recall to your Medtronic Sales Representative or call 763-391-9124.

Device

Medtronic Surgical Membrane Oxygenator
  • Modelo / Serial
    Lot Numbers: 10058759, 9984675, 9956368, 9916066, 989741, 9875810, 9866275, 9854094, 9828585, 9812351, 9421573, 9169873, 9044915, 8956269, 8938159, 8885755 and 8765243.   Serial Numbers: IH31608 - IH32031.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution USA including states of CA, CO, FL, IL, IN, KY, LA, MD, MI, MN, MO, NV, NJ, NY, OH, OK PA, TN, TX, UT, VA, and WI, and countries of LATVIA, ITALY, ARMENIA, RUSSIAN FEDERATION, POLAND, CHILE and CHINA.
  • Descripción del producto
    Medtronic Surgical Membrane Oxygenator. || Mis-printed Label: Medtronic 1-4500-2A, Recommended maximum blood flow range 5.0 - 8.5 L/min, Sterilized Using Ethylene Oxide, REF 61399402655, Manufacturer: Medtronic Inc., Minneapolis, MN 55432-5604. || Surgical Membrane Oxygenators are intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures. Additionally, the Integral Membrane Oxygenators are intended to cool and warm the blood by means of the integral heat exchange.
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Dirección del fabricante
    Medtronic Inc, 710 Medtronic Pkwy, Minneapolis MN 55432-5603
  • 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