Retiro De Equipo (Recall) de Catheter Mount

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Fisher & Paykel 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-2017-RN-01310-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-17
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    Fisher & paykel healthcare (fph) has been advised of an increased rate of split tubing cuffs in specific catheter mounts. a split tubing cuff on the catheter mount may potentially cause a leak.To date, fph has not received any reports of adverse events however there is the potential that a leak could lead to patient hypoxaemia if undetected.
  • Acción
    Fisher & Paykel Healthcare advises customers to identify any affected lot numbers of the RT021 Catheter Mount from their inventory. Affected products should be destroyed and disposed of.

Device

  • Modelo / Serial
    Catheter MountModel Number: RT021 Lot Numbers: From 2100089358 to 2100098462; and From 2100190360 to 2100241254ARTG Number: 273356
  • Manufacturer

Manufacturer