[4730254]
Infusion of cryopreserved autologous hpc, apheresis cellular therapy product (ctp) was scheduled for (b)(6) 2014. Three cryopreserved product bags were released from the stem cell lab and distributed to the pt bedside for infusion. Thaw and admin of the first and third units was performed without incident. Upon thaw of the second unit, leakage of the product into the secondary thawing bag was noted by the technologist performing the thaw. The technologist immediately identified the source of the leak and clamped the affected area. The leakage occurred at the base of the attached tubing (utilized for dispensing product/reagents into the cryo bag) just below where the tubing is heat sealed by the technologists at the completion of precessing. The integrity failure occurred at this location of the tubing where the tubing welds to the parent container and broke off at this area of the tubing. A 10 ml of product was lost as a result of the leakage. Due to medical necessity, it was determined by medical staff to infuse the product. Blood cultures were drawn on the pt and finalized on (b)(6) 2014 as "no growth". Post-thaw sterility samples were obtained from the affected product and sent for sterility testing. The post-thaw sterility testing was finalizing on (b)(6) 2014 as "no growth 14 days". Despite the product leakage, the pt received an optimal cd34+ cell dose. Per the pt operative report, the pt tolerated the procedure well and there were no expected and/or unexpected adverse reactions related to the product infusion.
Patient Sequence No: 1, Text Type: D, B5