Events

Retiro De Equipo (Recall) de T34L and NIKI 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-2016-RN-00245-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-30
  • 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-2016-RN-00245-1
  • 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
    Caesarea medical electronics (cme) has received reports of syringe pumps niki t34/t34l stopping and activating an alarm condition when being used in direct sunlight. if the user ignores or misinterprets the warnings on the pump display and restarts the pump, this may lead to an over infusion above the expected rate of delivery for the pump, which may result in adverse health consequences for the patient.
  • Acción
    The manufacturer - CME recommends customers avoid using the pump in sunlight or, if it is necessary for the patient to go outdoors, protect the pump from exposure (for example by placing it in a pouch or a bag). The manufacturer is working on a permanent solution.

Device

T34L and NIKI T34 Ambulatory syringe pumps
  • Modelo / Serial
    T34L and NIKI T34 Ambulatory syringe pumpsCaesarea Medical Electronics T34L Syringe PumpsCatalogue numbers: CE-100-104PSLNZ, CE-100-105PSLNZ, CE-100-106PSLNZ, CE-100-108PSLNZ, CE-100-109PSLAU All Pumps and Pump Housings manufactured from 2013 onwards Caesarea Medical Electronics NIKI T34 Syringe Pumps Catalogue numbers: CE-100-100PSAU, CE-100-102PS, CE-100-110PS All Pumps and Pump Housings manufactured from 2013 onwards ARTG Number: 131232
  • Manufacturer
    REM Systems Pty Ltd

Manufacturer

REM Systems Pty Ltd