Events

Retiro De Equipo (Recall) de HomeChoice PRO Automated Peritoneal Dialysis (PD) 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 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-2014-RN-00304-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-03-13
  • 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-2014-RN-00304-1
  • 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 is implementing additional warning in homechoice/homechoice pro device product labelling related to patients more vulnerable to unintended increased intraperitoneal volume (iipv), also known as overfill. specific populations using peritoneal dialysis (pd) therapy including neonates, infants, small children and any patient with significant heart or lung disease are more vulnerable to the negative effects of excessive retention of fluid in the peritoneal cavity that may be related to their dialysis therapy. overfilling with dialysate (iipv) or not draining enough fluid during pd therapy can result in excess fluid in the abdomen accompanied by patient symptoms.
  • Acción
    The additional warning identifies symptoms related to unintended IIPV that may occur in specific patient populations and provides specific instructions to the patient and/ or caregiver to follow if IIPV is suspected. For more details, please see http://www.tga.gov.au/safety/alerts-device-automated-peritoneal-dialysis-system-140318.htm .

Device

HomeChoice PRO Automated Peritoneal Dialysis (PD) System

Manufacturer

Baxter Healthcare Pty Ltd