Events

Retiro De Equipo (Recall) de Ultrafilter U9000 for use with AK96 and AK98 v1 dialysis machines

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Baxter Healthcare 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-2018-RN-00243-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-03-27
  • 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-2018-RN-00243-1
  • 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
    Baxter healthcare corporation has identified potential leaks during regular clinical use of the ultrafilter u9000. the leaks are caused by cracks near the header cap due to the stress of repeated disinfection cycles over the lifetime of the product. the current instructions for use (ifu) state the ultrafilter has a maximum lifetime usage of 90 days, or 150 heat disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles. in order to reduce the patient risk associated with the occurrence of leaks, the ifu will be updated to reduce the maximum lifetime usage to 60 days, or 100 heat disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles when the ultrafilter is used in conjunction with ak96 and ak98 v1 dialysis machines. other machines using these filters have a leak detector sensor that will trigger an alarm.
  • Acción
    Baxter is advising that operators may continue to use affected units with AK96 and AK98 v1 dialysis machines according to the new maximum lifetime usage criteria of 60 days, or 100 heat disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles. If Ultrafilters currently in use with AK96 and AK98 v1 machines have exceeded any of the new maximum lifetime usage criteria, it is recommended the filter be changed. Baxter will reset the AK 96 & AK 98 v1 monitor counters to the reduced maximum usage during the next scheduled preventive maintenance.

Device

Ultrafilter U9000 for use with AK96 and AK98 v1 dialysis machines
  • Modelo / Serial
    Ultrafilter U9000 for use with AK96 and AK98 v1 dialysis machinesProduct Code:112062Lot numbers: 6-1907-H-01 and higher (all unexpired units)ARTG Number: 131741(Baxter Healthcare - Filter, intravenous line)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd