Events

Retiro De Equipo (Recall) de Flocare Transition Giving Sets (Enteral feeding tube) Flocare Infinity Pack Giving Set MLL W/O DC – TransitionFlocare Infinity Bottle Giving Set – TransitionFlocare Infinity Pack Giving Set W/O DC & W/O MP - TransitionFlocare Infinity Bottle Giving Set W/O MP – TransitionFlocare Infinity Pack Mobile Giving Set – TransitionFlocare Infinity Pack Mobile Giving Set W/O MP - Transition

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Nutricia Australia 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-00063-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-15
  • 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-00063-1
  • 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
    Some users overseas have experienced issues with leakage and/or breakage of the enfit (white) transition adaptor included in the flocare transition giving sets (mll and mobile giving sets only). leakage could occur immediately after connection to a luer feeding tube and initiation of the feeding regime, as well as over time.The white transition adaptor may only be required by a small number of patients in australia to connect to a luer feeding tube.Higher volumes of leakage (spoilage of critical nutrition) might lead to an under infusion situation which, especially for critical and volume sensitive patients, can have a negative impact on patient health if it remains unnoticed for a longer period of time.
  • Acción
    Users who are using the white transition adaptor are advised that they can continue to use the affected products. However, when using, they are advised to check giving set adaptors for any minor defects, ensuring that connectors are not over-tightened which may cause cracking, and monitoring for leakage. Furthermore, as a precautionary measure, patients/parents/carers are advised to check for any leakages after initial connection and again after approximately 2 hours. If there are signs of leakage please change the set for a new one. It is anticipated that improved adaptors will be available in the market as of April 2016. For further information, please see http://www.tga.gov.au/alert/flocare-transition-giving-sets-enfit-transition-adaptors .

Device

Flocare Transition Giving Sets (Enteral feeding tube) Flocare Infinity Pack Giving Set MLL W/O DC...
  • Modelo / Serial
    Flocare Transition Giving Sets (Enteral feeding tube)Flocare Infinity Pack Giving Set MLL W/O DC – TransitionFlocare Infinity Bottle Giving Set – TransitionFlocare Infinity Pack Giving Set W/O DC & W/O MP - TransitionFlocare Infinity Bottle Giving Set W/O MP – TransitionFlocare Infinity Pack Mobile Giving Set – TransitionFlocare Infinity Pack Mobile Giving Set W/O MP - TransitionCodes: 595168, 595172, 595174, 595179, 595181, 595182All batch numbers affectedARTG #: 119666
  • Manufacturer
    Nutricia Australia Pty Ltd

Manufacturer

Nutricia Australia Pty Ltd
  • Source
    DHTGA