Events

Retiro De Equipo (Recall) de Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface.

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
    69746
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0531-2015
  • Fecha de inicio del evento
    2014-10-31
  • Fecha de publicación del evento
    2014-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131456
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Causa
    Medtronic initiated an urgent medical device recall for 66 distributed affinity fusiontm oxygenation systems with carmeda bioactive surface due to damaged heat exchangers. product affected by this issue is limited to model cb841 sold stand alone or incorporated in total systems ts1614r1 and ts1595r7. updated: recall was updated to incorporate three additional lots affected.
  • Acción
    On October 31, 2014, Medtronic field representatives began verbally notifying consignees of the issue, requesting the quarantine and return of un-used, affected product. As a follow-up to these verbal notifications, on November 12, 2014, a Medtronic "Urgent Medical Device Recall" letter dated November 2014 was hand delivered by Medtronic field personnel, and was also sent to account risk managers via UPS. The letter described the problem, the product affected by the recall and actions to be taken. Consignees were asked to immediately quarantine, remove and return all affected product to Medtronic; contact customer service at 1-800-854-3570 to initiate a return, and complete and return the attached Customer Confirmation Certificate via email to: RS.CFQFCA@Medtronic.com or fax to: Medtronic at 651-367-0612 to the attention of Customer Focused Quality. For questions they can contact their Medtronic sales representative or Lifeline Technical Services at 1-877-526-7890. UPDATE: Consignees were hand delivered an updated letter dated March 2015 concerning the additional affected product.

Device

Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface.
  • Modelo / Serial
    Lot number 12981001 with the following Serial Numbers:  8110138055 8110141155 8110141281 8110141459 8110138056 8110141162 8110141304 8110141469 8110138061 8110141167 8110141305 8110141471 8110138096 8110141168 8110141315 8110141497 8110139306 8110141182 8110141320 8110141518 8110139330 8110141184 8110141331 8110141527 8110139856 8110141188 8110141335 8110141533 8110140819 8110141193 8110141342 8110141587 8110140824 8110141215 8110141368 8110141604 8110140985 8110141219 8110141380 8110141605 8110141045 8110141222 8110141391 8110141613 8110141082 8110141230 8110141403 8110141616 8110141083 8110141238 8110141415 8110141621 8110141114 8110141240 8110141416 8110141705 8110141119 8110141244 8110141418 8110141731 8110141127 8110141247 8110141421 8110141739 8110141128 8110141253 8110141423 8110141750 8110141138 8110141258 8110141431 8110141782 8110141142 8110141260 8110141445 8110141788 8110141153 8110141279 8110141452 8110141798  UPDATED:  Lot # 13011880, 13 (serial # 8110141520), 13023057 (Serial # 8110141435 and 8110141539).
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: CA and FL. UPDATED: OUS: Czech Republic and Switzerland.
  • Descripción del producto
    The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is non-toxic, nonpyrogenic, and supplied sterile in individual packaging.
  • 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