Medical device manufacturer, Terumo, has issued a field safety notice concerning Advanced Perfusion System 1 with the following details:
Through internal assessment, the manufacturer has identified opportunities to improve patient safety by clarifying instructions in the Operators Manual for the Terumo Advanced Perfusion System 1. Updates to the Operators Manual will make the directions easier to follow and provide more accurate performance ranges that align with device operation.
The manufacturer is providing updated instructions to four sections of the Operators Manual, as the following addenda:
According to the local supplier, the affected products were not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 20 Jun 2014