The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning Alaris System Syringe Module, manufactured by CareFusion. The affected model number is 8110 and material number is 10930269.
According to the alert, the manufacturer 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 Point of Care Unit (PCU) (error code 351.6740); once cleared on the PCU the Syringe module remains unresponsive to key presses. This error could occur during an infusion causing an interruption of infusion.
Whilst connected to an Alaris System PCU at the time of error, upon power down and reattachment to any other module the PCU will continue to function as expected, there is no fault or flow on effect to the PCU module.
The manufacturer will adjust the syringe drive train assembly on the affected units and replace, if required.
For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2015-RN-00767-1
If you are in possession of the affected products, please contact your supplier for necessary actions
Posted on 25 August 2015