Events

Recall of Alaris Infusion pump administration sets

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by CareFusion Australia 316 Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00722-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00722-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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
  • Model / 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