It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the cardioplegia roller pump stopped working randomly during the procedure.There was no message on central control monitor (ccm) or pump display.The device was not changed out, as the pump was restarted by pressing button on the pump local control.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on (b)(6) 2014: there were no issues observed during set-up and preparation of the cpb circuit.During cpb, the clinical team observed that the cardioplegia roller pump had stopped.There was no loss of power observed (no blanking of the local display) and there were no indications of alert/alarm conditions that could have triggered a pump stop.The pump was found in the stop mode and the perfusionist (ccp) touched the start button and the cardioplegia roller pump was able to be re-started without issue.The pump was off for just a few seconds and there was no handcranking required.There no other issues with the cardioplegia roller pump the remainder of the procedure.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.
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