[74604843]
Bmt lab technologists performed a cell wash procedure for an unrelated allogeneic hpc, cord blood unit on (b)(6) 2016 in preparation for distribution of the washer product for infusion into a recipient at (b)(6). After completing centrifugation of the product as required by the wash protocol, the technologists removed the centrifuge bucket from the centrifuge. Upon visually inspecting the cell wash/infusion bag of the wash set residing in the centrifuge bucket support insert, it was determined that fluid had leaked from the cell wash/infusion bag and was being contained in the support insert. Bmt lab technologists immediately notified the quality management supervisor and quality coordinator of the findings. The quality management supervisor and quality coordinator went to the clean room facility to assist in assessing the incident. Visual examination of the cell wash/infusion bag revealed a very small pin hole at the base of the cell wash/infusion bag above the heat seal. On visual inspection, it does not appear that the heat seal is involved. As a result of the pin hole, approx 5ml of the product with a tnc of 2. 17 x 10^7 was lost. Measures were initiated for cellular product rescue and wash of the remaining product using dextran was completed. Cellular product rescue resulted in a tnc recovery of 93 x 10^7 resulting in a tnc cell done for infusion of 11. 63 x 10^7/kg. As a result of the cell wash/infusion bag integrity failure, the sterility of the unit was compromised. After review of the findings and due to the medical necessity, it was determined by the pt's transplant physician to infuse the product. The product was infused on (b)(6) 2016 without incident. Sterility testing results are pending as of the date of this report 03/31/2016.
Patient Sequence No: 1, Text Type: D, B5