| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01080-1 |
| Product Name/Description |
Alaris System Syringe Module
Model Number: 8110
Material Number:10930269
Serial Numbers: ALL distributed Alaris System Syringe modules in Australia to date
ARTG Number: 175353 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
There has been a previous notification (TGA Ref.: RC-2015-RN-00767-1) for devices manufactured during a specific time period, however further root cause analysis has shown all manufactured syringe drivers/modules prior to July 2015 are affected.
CareFusion has received service reports of a channel error on the Alaris System Syringe module model 8110.
A channel error is displayed on the syringe module in association with an audible and visual alarm on the attached PC Unit (error code 351.6740); once cleared on the PCU the Syringe module remains unresponsive to key presses until the next power cycle, or the module is detached and re-attached. This error could occur during an infusion causing an interruption of infusion.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
CareFusion will adjust the syringe drive train assembly on the affected units and replace, if required. This action has been closed-out on 06/09/2016. |
| Contact Information |
02 9624 9013 - CareFusion |