Medical device manufacturer, Terumo BCT, has issued a field safety notice concerning Trima Accel Automated Blood Collection System (Catalogue number: 81000, Serial number: All).
Terumo BCT is voluntarily recalling the Trima Accel system for the addition of a safety enhancement called Air Reduction Mitigation. This safety enhancement is being implemented to address the potential risk for an air embolism should a donor be prematurely connected to the Trima Accel system. They are aware of nine reported events related to this failure mode during the period of November 2008 to March 2013.
In the current process, when the tubing set cassette is lowered, a small amount of air is forced out the needle line. Once the cassette has completed lowering, the system then automatically begins removing air from the product bags. Approximately 135 mL of air is pumped out of the needle line. The system then prompts theoperator to close the clamps on the needle line and the sample bag line to perform the tubing set test. If the instructions are not followed in proper sequence and the donor is connected prior to lowering the cassette, there is the potential risk for the air to be delivered to the donor.
Terumo BCT is voluntarily implementing a safety enhancement in the TrimaAccel system software version 5.1.9 and version 6.0.6 that modifies the current product bag air removal and tubing set test sequence. This new functionality will redirect the air from the product bags and cassette into the vent bag instead of out the needle line. A larger vent bag was implemented on tubing sets in December 2011 which accommodates this new functionality.
The manufacturer advises users that during the time between this announcement and your center's implementation of the ARM functionality in version 5.1.9, upgrade to version 5.1.9 or upgrade to version 6.0.6, you should continue to use your Trima Accel system in accordance with the current operator's manual.
According to the manufacturer, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 29 April 2013