[66358151]
While packaging a kidney that had been recovered for transplant, an odor of sulfur or rotten eggs was detected. This was a 1-liter bag of belzer uw. The surgical recovery coordinator opened a second bag of solution, same lot number, and detected the same odor but not as strong. The lot number for the 1-liter bag of uw solution is bcd121416. The 2-liter bag also had an odor, lot # was bce122916. Notification to vendor of the solution occurred (b)(6) 2017. They are going to check their reserve stock for these lot numbers. The opo has sent the solution to lab for culturing. More information is coming in from the vendor of uw. The lots (b)(6) received were manufactured very recently and we have been told this odor occurs as a result of the solution being fresh. They have sent us literature supporting this information. We will continue with our cultures for a comparison. Both kidneys from this donor were discarded. Belzer uw notified (b)(6) today ((b)(6) 2017) they had tested a reserve sample from the same lot number and at hour 60, there has been no growth and nothing additional to report. (b)(6). (b)(6) is the expert in addressing compliance issues for sterile injectable pharmaceutical products. They will be running a 5-day method suitability test to make sure that all materials in congruent with the chosen media will support the growth of the organisms. After that is complete, the samples will be cultured for 14 days using the usp71 standard test. There will be notification if/when something positive comes up, as well as a preliminary report at 7 days - in conjunction with the tests (b)(6) will run on monday, a sample from each lot number will be drawn for the cdc and they will schedule shipping from (b)(6) to (b)(6). Expected shipment arrival will be on tuesday.
Patient Sequence No: 1, Text Type: D, B5