It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the sucker pump ramped up to a high speed with no input from the perfusionist.The pump was restarted and the issue was resolved.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the pump was set up without issue with a quarter inch polyvinyl chloride (pvc) tubing, and the occlusion was set accordingly for the procedure on (b)(6) 2019.Once on bypass, the team turned on the pump from the central control monitor (ccm) icon.The roller pump went to max speed, without input on the slider from the user.He automatically turned the pump off, and then tried to turn it back on with the ccm and was able to appropriately increase the speed with the slider.The team was able to use the roller pump without issue the remainder of the case.This occurrence only happened once during the procedure.They have used the roller pump since without issue.There was no harm or blood loss associated with the event.This over-speed event did not delay the continuation of the surgical procedure.
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