Medical device manufacturer, Terumo BCT Inc., has issued a field safety notice concerning COBE Spectra Bone Marrow Processing Tubing Set. The affected catalogue number is 70630, and the affected lot numbers are 10T15261, 10T15296, 12T15257, 05U15258 and 09U15271. The lot numbers 10T15261 and 10T15296 have an expiration date of 1 Oct 2013.
A leak at the tubing bond to the y-connector in the Bone Marrow Processing (BMP) set can, with very low probability, resulting in bacterial contamination of a transfusion product. Terumo BCT is aware of four reported events related to a leak at the tubing bond to the y-connector in the BMP set that did not result in adverse event and does not consider this failure mode a systemic issue. If the contaminated product is not tested prior to transfusion, patients may experience serious infections and other related serious adverse events.
The manufacturer advises users not to use the affected products. It has implemented corrective actions to improve the manufacturing process for bonding the y-connector to the tubing. For example, 100% inspection was added to the manufacturing operating procedure to verify bonding specifications for the bond to the bone marrow bag.
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 16 October 2013