Terumo BCT of Lakewood, Colorado, recalled the Trima Accel Automated Blood Collection System for the addition of a safety enhancement called Air Reduction Mitigation (ARM). This safety enhancement is being implemented to address the potentially fatal risk of an air embolism should a donor be prematurely connected to the Trima Accel system.
There is the potential risk for an air embolism if air is delivered to a donor when the donor is connected prior to completely loading the tubing set. The present version of the software recognizes this user error and proceeds to redirect the air from the product bags and cassette out the needle line, which may cause a potentially fatal air embolism. Terumo BCT is aware of multiple reported events related to this failure.
Given this potential fatal risk, Terumo BCT implemented a safety enhancement in the Trima Accel 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 will redirect the air from the product bags and cassette into the vent bag instead of out the needle line.
All customers are required to upgrade to either software version 5.1.9 or version 6.0.6.
See the Recall