Medical device manufacturer, Terumo® Cardiovascular Systems (CVS) Corporations, has issued an urgent field safety notice concerning Terumo® Advanced Perfusion System 1.
The manufacturer has received reports of two instances where users were confused about the proper adjustment of the local control knobs of the electronic patient gas system on the Terumo® Advanced Perfusion System 1.
Their investigation revealed that the issue resulted from insufficient labeling on the local control knobs of the electronic patient gas system and a lack of sufficient information in the Terumo System 1 Operators Manual. User confusion about adjustment of the local control knobs could result in a delay in detection and correction of incorrect gas composition to the patient. There have been no reports of patient injury as a result of this issue.
The manufacturer will provide additional labeling on the Terumo System 1 electronic patient gas system local controls and provide more specific instructions in the Operators Manual through an addendum.
According to the local supplier, the affected devices were not distributed in Hong Kong. If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 3 July 2012