Events

Retiro De Equipo (Recall) de Atrium Trocar Catheters, Sizes 8Fr to 32FrProduct Code Numbers: 8408, 8410, 8412, 8416, 8420, 8424, 8428, 8432

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet Australia 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-2016-RN-01419-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-02
  • 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-2016-RN-01419-1
  • 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
    It has been identified that atrium trocar catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. this graphical icon shows there are 6 side holes on the trocar catheter; however, the correct number of eyelets on the trocar catheter is 2 side holes.To date, atrium has received two complaints of insufficient drainage, with injury, as a result of selecting trocar catheters that had fewer eyelets than displayed on the product label. although the use of a trocar catheter with two eyelets may be effective in most patients, the potential risks related to use of the trocar catheter with 2 eyelets are: incomplete drainage of pleural effusion or pneumothorax, the need for repeat chest tube or pleural drain insertion, and surgical site infection.
  • Acción
    Maquet is advising customers to remove affected product from supply/inventory and place in quarantine. All sterile and un-used affected products are to be returned to Maquet for credit. Replacement product is not available as all Trocar Catheters have been discontinued however Maquet is providing information to customers about substitute product from alternative suppliers. This action has been closed-out on 25/05/2017.

Device

Atrium Trocar Catheters, Sizes 8Fr to 32FrProduct Code Numbers: 8408, 8410, 8412, 8416, 8420, 842...
  • Modelo / Serial
    Atrium Trocar Catheters, Sizes 8Fr to 32FrProduct Code Numbers: 8408, 8410, 8412, 8416, 8420, 8424, 8428, 8432All lot numbersARTG Number: 97358
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA