Events

Retiro De Equipo (Recall) de Medtronic DLP Adapters and Pressure Display Sets DLP Extension Line Adapters 20 in length, GDLP Antegrade/Retrograde Adapter, DLP Cardioplegia Adapter with Pressure Port, DLP Pressure Monitoring Extension Line Adaptors, DLP Pressure Disposable Pressure Display Sets

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia Pty Ltd.

¿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
    RC-2017-RN-00805-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-06-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00805-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Medtronic recently identified small pinholes approximately 1mm or less in diameter in single packaging configuration. medtronic has performed an internal investigation and all products configured and manufactured since march 1 2016 are potentially affected. this result is a potential sterile barrier breach. zero complaints have been received for the affected lots. potential patient harm is infection, which could result in secondary harm if a sterile barrier breach in the packaging is present, but not detected prior to use.
  • Acción
    Medtronic is Recalling affected stock from the Market.

Device

Medtronic DLP Adapters and Pressure Display Sets DLP Extension Line Adapters 20 in length, GDLP A...
  • Modelo / Serial
    Medtronic DLP Adapters and Pressure Display SetsDLP Extension Line Adapters 20 in lengthProduct Code: 11001GDLP Antegrade/Retrograde AdapterProduct Code: 13001DLP Cardioplegia Adapter with Pressure PortProduct Code: 15004DLP Pressure Monitoring Extension Line AdaptorsProduct Codes: 25009, 25010DLP Pressure Disposable Pressure Display SetsProduct Codes: 61000, 62000ARTG Numbers: 126007 and 130994
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA