| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01565-1 |
| Product Name/Description |
Alaris System Point of Care Unit (PC unit)
Model Numbers: 8000, 8015
All software versions and Serial Numbers affected
ARTG Number: 146664 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has received reports of the Alaris System PC units operating on battery power where the low battery alarm and/or the very low battery alarm, which should activate when 30 minutes and 5 minutes of estimated battery runtime remains, are not being triggered before the PC unit displays a battery discharge alarm and all infusion channels are stopped. This issue does not occur if device is plugged into AC outlet. If the operator is unaware of a low battery power state because alarms have not been generated, there will be an interruption of infusion due to lack of power. The infusion will stop until the user can provide alternate means of power/replacement device. Root causes: batteries not adequately maintained, use of non-authorised batteries, batteries near the end of usual life and battery conditioning test performed in maintenance mode.
In past 12 years there have been 58 reports of this issue globally. The manufacturer is not aware of any report of injury in Australia. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
CareFusion is advising customers of the following. Whenever possible, keep the PC unit plugged into AC power. If the PC unit is disconnected from AC power and the battery is used, ensure that the PC unit is returned to the AC power as soon as possible. After the device has been used on battery power, ensure that the battery is fully recharged prior to using the device on battery power again. Special care should be taken for critical infusions to ensure that AC power is used whenever possible and that batteries are fully charged before the battery is used. (e.g. when transporting patients).
CareFusion is also providing customers with updates to the user manual and battery conditioning and battery maintenance processes in the form of a User Manual Addendum for Battery Care and Maintenance and also Service Bulletin 592.
This action has been closed out on the 08/11/2018. |
| Contact Information |
02 9624 9033 - CareFusion Australia |