Events

Retiro De Equipo (Recall) de T34 Ambulatory Syringe Pumps

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por REM Systems 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-00681-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-20
  • 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-00681-1
  • 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 there can be a 2mm +/- overall length difference between various manufacturers pp3 batteries that could be used in niki t34 ambulatory syringe pumps. this could result in movement within the battery housing leading to a possible loss of connection, resulting in the pump powering down and a possible under infusion of pain medication occurring.
  • Acción
    If a battery within the NIKI T34 housing appears loose, careful adjustment of the battery connections may be required as detailed in the Customer letter

Device

T34 Ambulatory Syringe Pumps
  • Modelo / Serial
    T34 Ambulatory Syringe Pumps Catalogue Numbers: CE-100-100PSAU, CE-100-102PS, CE-100-110PS All Pump Serial Numbers ARTG Number; 131232(REM Systems - Infusion pump, syringe)
  • Manufacturer
    REM Systems Pty Ltd

Manufacturer

REM Systems Pty Ltd