| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00774-3 |
| Product Name/Description |
Alaris LVP module (model 8100) (General purpose infusion pump)
Mulitple serial numbers
Pumps manufactured between August 2010 and July 2011
ARTG Number: 146664 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
The Alaris Pump module may experience intermittent motor stall. Most of the motor stalls reported appear to occur intermittently at high infusion rates (typically over 900 ml/hr) but CareFusion cannot rule out the possibility of occurrence at lower infusion rates. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
CareFusion is advising users to consider the clinical risk of using these pumps in high risk patients undergoing infusions at high rates and to have alternative pumps available. If a motor stall occurs the users are being asked to quarantine the pump and to contact CareFusion. |
| Contact Information |
1300 729 258 - Carefusion Technical Service Team |