[3987672]
Pt infusion of cryopreserved autologous hpc, apheresis cellular therapy product (ctp) was scheduled for (b)(6) 2014. At time of transplant, bmt lab technologists inspected and issued the ctp per protocol in preparation for transplant. Bmt lab technologists stated that the physical integrity of all freeze bags was intact upon visual examination of ctp product at time of issue of ctp. Ctp was transported to pt bedside for thawing and infusion of thawed cells. Upon performing bedside verification of freeze bag integrity and labeling in preparation for product thaw, bmt lab tech stated they observed a small line on the surface of the freeze bag with unique id (b)(4). Upon further inspection of the freeze bag, it was determined that the observed line on the freeze bag surface was actually a fracture extending the entire vertical length of the bag from the base of the bag to just under the outer most port of the top of the bag. The bmt lab technologist in collaboration with the clinical nurse infusionist notified the attending physician of the observation of the fractured freeze bag. It was determined not to infuse the cells contained in the damaged freeze bag due to the nature and extent of the fracture of the freeze bag. The physician directed the bmt lab technologist to return the fractured freeze bag to the lab and to issue an additional/substitute product bag for infusion to replace the damaged product. Freeze bag with unique id (b)(4) was issued and infused. The infused cd34+ dose met the minimum criteria of 2. 0 x 10 to the power of 6/kg.
Patient Sequence No: 1, Text Type: D, B5