Patient presented to our facility on (b)(6) 2020 with malaise and fevers and was found to be positive for m.Chimaera.The patient has a history of ct surgery on (b)(6) 2014, with heater-cooler serial # (b)(4) used, and a subsequent ct surgery on (b)(6) 2019, with heater cooler serial # (b)(4) used.Manufacturer livanova was contacted and made aware of the infection.The machine used in the second surgery, serial # (b)(4), was on loan from the manufacturer and was also used on a second patient in our facility found to be m.Chimaera positive.We no longer have the loaner machine that was returned to the manufacturer on 05/6/2020.Fda safety report id# (b)(4).
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