Important Safety Alerts

Medical device manufacturer, Terumo® Cardiovascular Systems (CVS) Corporation, has issued an urgent field safety notice concerning Terumo® Advanced Perfusion System 1.

The manufacturer has received multiple reports regarding battery capacity issues in which the Terumo® Advanced Perfusion System 1 displayed some or all of the following symptoms:

• The system displayed false information, indicating battery capacity (i.e. hours/minutes remaining) when the batteries have little or no remaining capacity
• The system unexpectedly shut down without warning when running on battery power
• Batteries were completely depleted
• Batteries did not retain their charge as intended

Terumo CVS' investigation determined that failure to properly charge and maintain the Terumo System 1 batteries can cause the 'Estimated Battery Time Remaining' indicator (on the Power Sub tab of the CCM) to display more battery time than is actually available

The potential harm is exacerbated if the user believes the batteries are fully charged because the system falsely over-reports the available battery time. There have been no reports of patient injury as a result of this issue. The manufacturer is developing a Field Correction to prevent the 'Estimated Battery Time Remaining' indicator from falsely over-reporting available battery time.

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