Date of occurrence: (b)(6) 2018.Patient was being treated for cabg "went on bypass, the staff noticed the patient's arterial blood was not fully oxygenated while at the maximum fi02 setting.They were able to troubleshoot that the issue was with the mixer and quickly changed it out within a minute of diagnosis, so there wasn't any delay in treatment.Patient was fine during the procedure as well as doing fine now.After the event the biomed evaluated the mixer and observed the "knob can turn past the 21% stop".The customer reported that a performance verification was completed prior to the mixer being placed into service with the patient.The customer reported the last preventative maintenance that was completed on the mixer was done on june 8, 2018.See mfr # 2020676-2018-00010 for the second report for this device.
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