Events

Retiro De Equipo (Recall) de Alaris Infusion pump administration sets

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CareFusion Australia 316 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-00722-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-19
  • 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-00722-1
  • 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
    The bd alaris infusion pump administration sets require priming prior to use as described in the directions for use (dfu). bd has identified a potential issue with the bd alaris infusion pump administration sets manufactured during january 2017 through march 2018. the issue pertains to the back check valve and the ability to prime the administration sets. the manufacturer has determined the root causes leading to this issue are associated with: 1. excessive solvent used to connect the tubing to the back check valve leading to an obstruction of the fluid path, thus preventing the priming of the set. 2. a higher “cracking” pressure of the back check valve.To date, no injuries have been reported as a result of this issue.
  • Acción
    CareFusion is advising that users can continue to use the product. When a set cannot be appropriately primed, users may be able to increase the pressure by gently squeezing the IV bag following these steps: 1. If no drops are observed, gently squeeze the bag at the fluid level with one hand once. Observe if set is able to prime. 2. If no drops are observed repeat this up to 3 times. 3. If this method is not effective discard and replace the administration set. 4. Consider having additional administration sets available in clinical areas where high risk infusions are administered.

Device

Alaris Infusion pump administration sets
  • Modelo / Serial
    Alaris Infusion pump administration sets Product Codes: 2120-0500 , 2420-0007 , 2420-0500, 10015489, 11426965 ARTG Number:125916
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd