Events

Retiro De Equipo (Recall) de Heater Unit HU 35

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-2017-RN-00917-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-07-25
  • 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-00917-1
  • 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
    Getinge has released revised disinfection procedure for heater unit hu 35. heater unit hu 35 is used during extracorporeal life support (ecls) in intensive care units to maintain the patient’s blood temperature via an oxygenator heat exchanger. there is no contact between the blood stream of the patient and the system water circulating through the heat exchanger. maquet cardiopulmonary as well as different national competent authorities have received isolated reports confirming the presence of bacterial contamination in the system water of hu 35 including mycobacterial counts. however, maquet cardiopulmonary has not received any reports that a mycobacterial infection or any other bacterial infection would have been caused by a heater unit hu 35.
  • Acción
    The current published Instructions for Use chapter 6 “Cleaning and Disinfection” for HU 35 Heater Units will be replaced by a new Instructions for Use (IFU). Action to be taken by the user: 1. Complete and return the enclosed Acknowledgement Form as soon as possible to your local Maquet representative; 2. Incorporate this revised procedure into your operating processes; 3. Conduct any training necessary for the revisions; 4. Continue to monitor the hygiene (contamination levels) in accordance with your internal practices; 5. Immediately report any contamination findings to your local Maquet representative by a complaint; and 6. Remind all users that the HU35 is not to be opened or filled in the operating room.

Device

Heater Unit HU 35
  • Modelo / Serial
    Heater Unit HU 35All Models and Serial NumbersARTG Number: 144010
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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