Urgent - Medical Device Recall - Trima Accel Automated Blood Collection System
DATE RECALL INITIATED: April 26, 2013
PRODUCT / LOT NUMBER
Catalog Number: 81000
Serial Numbers: All
Terumo BCT, Inc.
Terumo BCT is voluntarily recalling the Trima Accel system for the addition of a safety enhancement called Air Reduction Mitigation (ARM). 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.
There is the potential risk for an air embolism if air is delivered to a donor due to the failure mode of operator error in which the donor is connected prior to completion of loading the tubing set when using the Trima Accel system. Terumo BCT is aware of nine reported events related to this failure mode. Given this potential risk, Terumo BCT is voluntarily implementing 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 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.
All customers are required to upgrade to either software version 5.1.9 or version 6.0.6 and are asked to complete the attached Acknowledgement form and fax or email it to Terumo BCT by May 31, 2013.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.