Events

Recall of Keypad of Alaris LVP module (Component of a general purpose infusion pump)

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-2012-RN-00788-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00788-3
  • 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
    Alaris pump module model 8100 that contains the door assembly with keypad part number tc10005926 may be at risk of the door keypad overlap separating from the keypad assembly. when the pump module door keypad overlay has delaminated (loose, peeled away or separated from the door assembly) this could cause a potential for fluid ingress which could lead to a keypad malfunction causing termination of infusion with alarm.
  • Action
    The sponsor is providing work around instructions to mitigate the risk and will be replacing affected units.

Device

Keypad of Alaris LVP module (Component of a general purpose infusion pump)
  • Model / Serial
    Keypad of Alaris LVP module (Component of a general purpose infusion pump); Module Model: 8100Part number: TC10005926 Manufactured between: 5 October 2011 to 9 February 2012Multiple Serial NumbersARTG Number: 146664
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd