Events

Retiro De Equipo (Recall) de Trellis 6 and Trellis 8 Peripheral Infusion System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Covidien 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-2015-RN-00267-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-26
  • 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-2015-RN-00267-1
  • 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
    Covidien (now medtronic) is conducting a recall of the trellis 6 and trellis 8 peripheral infusion systems due to potential for a sterility breach of the outer packaging or pouch material of all lots manufactured. a breach of the outer pouch may compromise the outside surface sterility of the inner pouch and does not directly affect the sterility of the device components within the inner pouch. this potential for a sterile breach in the outer pouch material was discovered during standard internal packaging tests. the breach in the pouch barrier is likely not detectable by visual inspection of the product. covidien has identified possible causes for the pouch damage and has taken actions to prevent distribution of product that may be affected by this issue.Covidien has received no complaints and is not aware of any patient injury or death related to the issue.
  • Acción
    Covidien is Recalling all affected units from the market and will issue a credit for unused and unexpired devices. This action has been closed-out on 09/08/2016.

Device

Trellis 6 and Trellis 8 Peripheral Infusion System
  • Modelo / Serial
    Trellis 6 and Trellis 8 Peripheral Infusion SystemARTG Number: 229708
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien 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