Important Safety Alerts

Medical device manufacturer, Terumo BCT, has issued a field safety notice (FSN) concerning Spectra Optia Apheresis System. All serial numbers are affected.

The manufacturer is recalling the sensor because a small number of these components have failed either disrupting or prematurely ending an ongoing apheresis procedure. The manufacturer has investigated all reported Return Line Air Detector (RLAD) failures and identified the following failure modes:

• Electrostatic discharge (ESD) during manufacturing or installation can damage the RLAD component, eventually resulting in failure of the component. When this occurs, the Spectra Optia system is placed in a safe state and cannot be used until it is serviced. ESD protective measures were implemented to resolve this issue.
• During a procedure, air can be falsely detected in the return line when the plastic tubing decouples (slightly moves away) from the sensor. When this occurs, an "Air detected in the Return Line" alarm is generated by the system. After completing an air recovery procedure, the apheresis procedure can sometimes be continued by confirming there is no air in the return line and verifying that the return pump tubing makes good contact with the RLAD sensor. However, if sequential air recoveries are required, the system may terminate the procedure. The procedure must then be re-initiated with a new tubing set. The manufacturer has modified the RLAD sensor to eliminate this "decoupling" and the resulting false RLAD alarm.

According to the manufacturer, the primary risk to health occurs during mononuclear and granulocyte cell collection procedures, where patients/donors receive a mobilizing agent (e.g., G-CSF) prior to the cellular collection. Should an RLAD failure result in the premature termination of a cell collection procedure, an additional procedure and administration of G-CSF could be required.

The manufacturer advises users of the followings:

• Continue to use Spectra Optia system.
• If users experience "Air detected in the Return Line" alarms that users cannot clear, and users do not see air in the return line, they should call the Terumo BCT Support center. Specialists will review the alarms and coordinate repair of the device, if needed.

The manufacturer has modified the RLAD Sensor. Based on extensive laboratory testing and field validation data, the manufacturer expects the modified component to reduce the occurrence of false air detections due to tubing decoupling. The manufacturer will replace the existing RLAD sensor with the redesigned component.

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

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

Posted on 21 July 2014