Events

Recall of CADD- Solis Ambulatory Infusion Pumps

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smiths Medical Australasia 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-2015-RN-00447-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00447-1
  • 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
    Smiths medical has become aware of an issue with an intermittent occurrence of binding of the locking assembly on some cadd-solis pumps. binding of the cassette/ keypad lock can occur after latching the cadd-solis medication cassette reservoir or administration set “disposable” to the pump. when binding occurs, it can prevent the key from fully rotating the cassette/ keypad lock to the locked (engaged) position. to start an infusion with cadd-solis pump models 2111(grey keypad) and 2112 (yellow keypad), and model 2120 (vip), when in pca mode, the lock must be fully engaged. cadd-solis pump model 2120 will start in all other delivery modes without the cassette/ keypad lock being engaged.Smiths medical has received no reports of serious injury or death related to this issue.
  • Action
    Smiths Medical has resolved the problem associated with the binding of Cassette/ Keypad Locks and implemented a lubrication step during manufacture and during servicing at Smiths Medical Authorised Service Centres. A customer service representative will contact users to arrange for repair of their CADD-Solis Pumps. This action has been closed-out on 08/08/2016.

Device

CADD- Solis Ambulatory Infusion Pumps
  • Model / Serial
    CADD- Solis Ambulatory Infusion Pumps Model Numbers 2111, 2112, and 2120Serial Numbers: 1061043 through 1067598 ARTG Number: 109467
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd