Urgent Medical Device Safety Alert
DATE NOTIFICATION INITIATED: January 25, 2012
PRODUCT / LOT NUMBERS:
CaridianBCT Trima Accel System Disposable Tubing Sets
All Lot Numbers prior to January 2012 date of manufacture
CaridianBCT has become aware of a defect that occurred during the manufacturing of Trima Accel tubing sets. During assembly of the AC/draw/return manifold, the automated equipment inserted the return line tubing into the manifold in such a way that the tubing may be bent inside the manifold. Not all tubing sets are affected, and the expected frequency of occurrences is very low, estimated to be 1 in 1667. Caridian BCT has received no reports of this defect from users of the Trima Accel system.
Prior to loading, customers are asked to visually verify that the return line tubing (blue stripe) is not bent in the manifold and to not use any individual sets that contain a suspect manifold. Customers should also contact the CaridianBCT support center to arrange for product return.
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.