| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00793-1 |
| Product Name/Description |
Alaris System Infusion PC Unit
Model Number: 8015
Manufactured between 11 September 2012 and 29 March 2013
ARTG Number: 146664 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Alaris PC Units model 8015 manufactured between September 11, 2012 and March 29, 2013 may display a system error code 133.6080 due to a failure with the super capacitor (C245) at power up on the Alaris PC Unit logic boards.
The error code will cause an audible and visual alarm to sound and could cause a delay of therapy at power up only. The error code will not occur during infusion. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Carefusion is advising users that if the error code is observed, to remove the unit from use and use a different unit where available. Carefusion will be correcting all affected units.
This action has been closed out on 06/08/2019 |
| Contact Information |
02 9624 9033 - CareFusion Australia |