| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00138-1 |
| Product Name/Description |
Alaris Syringe Module Model 8110
Software version v9.15
ARTG Number: 175353 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Becton Dickinson (BD) has identified a software anomaly with the Alaris Syringe Module, model 8110; software version 9.15. This anomaly may cause a small percentage of syringe infusions to unexpectedly stop when an infusion is transitioning from one state to another. Infusion transitions that may be impacted by the failure are:
- A complete bolus transitioning to a continuous infusion
- A basic, continuous or intermittent infusion transitioning to Near End of infusion (NEOI) state
- A basic, continuous or intermittent infusion transitioning to a Keep the Vein Open (KVO) state
The error code will cause an audible and visual alarm on the Alaris PC unit and scroll a channel error message on the Alaris Syringe module. Becton Dickinson is not aware of any report of injury attributed to this defect. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
BD will arrange for a product correction (i.e. software upgrade) to mitigate the issues. In the interim, users are advised that if error code 351.6610 occurs, the user can clear the channel error by pressing “CONFIRM”. After the channel error is cleared on the PC unit, the user can detach and re-attach the module to restart the infusion, or power off the PC unit and then power back on to restart a new infusion. The user should replace the affected Syringe module as soon as possible and isolate the Alaris Syringe module that exhibits the channel error code.
This action has been closed-out on 21/03/2018. |
| Contact Information |
02 9624 9033 - Becton Dickinson |