Events

Rappel de Alaris System Pump module (LVP) 8100 and Air-In-Line (AIL) Sensor Kits Alaris System Pump module (LVP)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par CareFusion Australia 316 Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00140-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-30
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00140-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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 ...
  • Modèle / numéro de série
    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