Medical device manufacturer, Terumo Cardiovascular Systems Corporation, has issued a medical device safety alert concerning Base for Terumo Advanced Perfusion System 1 (Catalogue number: 801763).

Terumo Cardiovascular Systems (CVS) has become aware of a remote possibility that Terumo Advanced Perfusion System 1 could experience a spontaneous loss of system power. Terumo CVS is issuing a safety notice because the User's Manual for the Terumo System 1 does not provide user instruction for responding to such an event.

According to Terumo CVS, five reports of spontaneous power loss for the Terumo System 1 have been received between 2003 and 2012:

• In all reports, the systems lost full power and did not switch to battery backup. This occurred without warning.
• In one report, the system re-booted automatically after approximately 30 seconds. In the remaining reports, the system regained power after the user toggled the main power switch.
• In all reports, the user was able to establish full function for the remainder of the case and the system did not exhibit the malfunction again.

The complete loss of system power would result in loss of all patient support functions, including arterial blood flow, myocardial protection, venting and suction capabilities, safety systems, system alarms and system information. Depending on the response of the clinical team and the availability of backup equipment, a prolonged lack of such support could result in death or serious injury.

The manufacturer supplemented that the potential patient injuries range from no injury to varying degrees of neurologic dysfunction, cardiac dysfunction due to inadequate myocardial protection, end organ dysfunction, or death in the case of an extended period of no flow.

In the event a user experiences a spontaneous loss of power without the automatic initiation of the battery backup system, Terumo CVS recommends:

• The user first ensures that the entire system has lost power by checking the central control monitor (CCM), the local pump displays, the LED indicators on the modules, and the battery status indicator on the front of the system.
• Once certain the entire system has lost power, turn the main power switch on the front panel to the "OFF" position then to the "ON" position.
• Contact Terumo CVS Customer Service immediately upon conclusion of the case.

According to the local supplier, the affected products have not been distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 24 December 2012