Important Safety Alerts

The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning LIFE 18 apheresis system, manufactured by Miltenyi Biotec.

Tests in laboratory have shown the possibility that under certain circumstances the LIFE 18 apheresis unit will not interrupt the treatment and stop all pumps if a blood leak occurs in the tubing of the Disk Separator. According to the manufacturer, this type of a severe blood leak in the fluid path of the Disk Separator during a treatment has been observed for the first time in more than 30.000 treatments performed with the separator.

The manufacturer is developing revised software which will be able to correct the gap in the blood leak detection of the LIFE 18 apheresis unit. As an intermediate preventive action, the manufacturer advises users of the followings:

• Make sure that the patient connected with the LIFE 18 apheresis unit never remains unattended during the treatment.
• Check for tubing set integrity regularly during the treatment.
• When the blood leak is detected, users should stop the treatment and replace the defective separator.

For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON362398

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

Posted on 22 January 2014