[6429710]
Patient underwent autologous hpc, apheresis cellular therapy product (ctp) collection on (b)(6) 2015. The product was received into the stemcell laboratory, sampled for required testing, and processed per laboratory protocol. At the final step of processing after addition of all components/product into the cryo bag through use of the attached cryo bag tubing, a tubing integrity failure occurred as the technologist removed excess air from the cryo bag utilizing tubing from the bag attached via luer lock. The tubing set containing dispensing lines attaches via a y connection to the parent tubing that rises from the top of the cryo bag. It was at this y connection that the tubing integrity was compromised and detached from the y connection as the technologist removed the excess air contained within the freeze bag. After the tubing detached, the bmt laboratory technologist ensured that the exposed hub that the tubing seals over maintained sterility and did not touch any object/surfaces. The detached tubing was reseated at the y connection and was immediately clamped. An available alternate luer lock connection was utilized to complete the removal of excess air from the cryo bag. The product processing was completed, the ctp cryopreserved, and the product stored in ln2 vapor phase for long term storage until the time of transplant. As a result of the patient's collected cd34+ cell dose, medical leadership determined that the compromised product bag will be stored as a back up product and will not be infused at the time of the initial stem cell transplant. In the event that the back up product is infused in the future, sterility testing will be performed on a thawed product sample. 1316900277-2015-0001.
Patient Sequence No: 1, Text Type: D, B5