Important Safety Alerts

Medical device manufacturer, TECHNIDATA SAS, has issued a field safety notice concerning a defect affecting all versions of the TD-Synergy Blood Bank module connected to TD-Synergy (known as LIS connection). The Blood Bank module retains one of the two blood group determinations whereas it should not retain any and should alert the users. This issue identified at the Montfort site (Canada) occurs when the two blood group determinations are received in the same ASTM message. The TD-Synergy Blood Bank module version is V04.71.B, but this defect could potentially occur in all versions. The identified scenario is the following:

• For a patient with no known blood group on the Blood Bank module, when an ASTM message is received from TD-Synergy including two different blood group determinations, the Blood Bank module retains one of the determinations as the blood group for this patient whereas it should not retain any and should alert the users.

This defect can occur if the following conditions are met:

• Blood Bank module connected to TD-Synergy (LIS connection)
• Unknown Blood group on the Blood Bank module
• Two different Blood group determinations for the same sample in the first transmission of the ASTM file
• Blood Bank module is set with extended compatibility (see General settings parameter)
• Specific Dongle option « Double determination on a single sample »

The severity is considered very high as the defect could lead to an incorrect transfusion. The probability is assessed as low given the number of conditions to meet.

The manufacturer advises users to find correction packages corresponding to the TD-Synergy Blood Bank module on the TECHNIDATA website and contact their Support Team if the corresponding correction package is not available on the website.

According to the manufacturer, the affected products were distributed in Hong Kong.

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

Posted on 19 April 2013