Events

Retiro De Equipo (Recall) de Alaris System Pump module (LVP) 8100 and Air-In-Line (AIL) Sensor Kits Alaris System Pump module (LVP)

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-2017-RN-00140-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-30
  • 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-2017-RN-00140-1
  • 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 manufacturer has received reports of air-in-line (ail) alarms that have occurred when no air is observed in the line. while the pump is infusing, the system may indicate that an ail alarm has occurred when no air is in the line. in some cases, these false ail alarms may be attributed to a faulty ail sensor.To date, bd is not aware of any report of injury attributed to this defect in australia.
  • Acción
    If AIL alarm occurs, the user should do the following: 1. Determine if there is air visible in the tubing that has caused the alarm. If there is air visible in the line, clinician can evaluate whether or not it is clinically significant and remove it according to hospital protocol, if necessary. 2. If no air is observed, ensure that tubing is properly installed in AIL Detector. False AIL alarms may occur if tubing is not properly installed. When inserting the tubing into the AIL detector, use a fingertip and firmly push the tubing toward the back of the AIL detector. 3. If AIL alarms continue to reoccur on the same pump, after air has been removed from the line and tubing has been properly loaded, the AIL sensor may be faulty. If the AIL sensor needs to be replaced, BD will provide replacement parts at no charge. If a pump has been identified as having recurring AIL alarms without evidence of air in the line, then replace the AIL sensor with a new AIL sensor provided by BD.

Device

Alaris System Pump module (LVP) 8100 and Air-In-Line (AIL) Sensor Kits Alaris System Pump module ...
  • Modelo / Serial
    Alaris System Pump module (LVP) 8100 and Air-In-Line (AIL) Sensor Kits Alaris System Pump module (LVP) Model: 8100Manufactured between October 2011 and June 2015ARTG Number: 146664Air-In-Line (AIL) Sensor Kits Part Numbers: 147083-102, 49000221 Distributed between October 2011 and June 2015ARTG Number: 146664
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd