| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00447-1 |
| Product Name/Description |
CADD- Solis Ambulatory Infusion Pumps
Model Numbers 2111, 2112, and 2120
Serial Numbers: 1061043 through 1067598
ARTG Number: 109467 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
1800 654 949 - Smiths Medical Australasia Pty Ltd |