| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00171-1 |
| Product Name/Description |
CADD-Solis Ambulatory Infusion Pumps
This issue affects CADD-Solis v4.1, v4.2 and CADD-Solis VIP v1.3, v1.4, v1.5
ARTG 396633
(Smiths Medical Australasia Pty Ltd - Infusion pump, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
In 2017, Smiths Medical changed the Low Sensitivity Air in Line alarm threshold in an effort to reduce false alarms. A review of complaints before and after the change found that the change had no impact on the type or rate of complaints. Therefore, Smiths Medical is reverting the Low Sensitivity Air In Line alarm threshold to the previous settings in alignment with industry standards. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should locate all affected pumps in their possession and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigation.
Be aware of alarms for air in line and follow the instructions for use. When available, upgrade to the latest software version, including the reversion back to the previous Low Sensitivity threshold.
Once available Smiths medical will contact customers you to schedule the implementation of the software update. |
| Contact Information |
02 8335 1010 - George Koumantakis |