It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the pump displayed erratic numbers for flow.They had to came off pump to change the pump head.Per clinical review on (b)(6) 2017: per certified clinical perfusionist (ccp), about 5 minutes after the start of cpb, the flow display on the arterial roller pump became erratic with the calculated flow jumping from 5 l/min to 2 min or 0.5 l/min to 9 l/min.According to ccp the actual pump speed and flow rate was not changing, just the calculated flow display was erratic.He stated the pump displayed reset in the message window, but the pump did not stop.Since this occurred during the first minutes of cpb and the aortic cross-clamp had not yet been applied and cardioplegic arrest had not been induced, the team elected to wean the patient off cpb and change out this roller pump as they were not comfortable with the behavior of the pump.The patient was weaned successfully and was hemodynamically stable.The arterial line was clamped and the tubing was removed from the pump.The pump was removed from the base and a back-up pump was placed on the base and the tubing was placed in this new pump.Occlusion was checked and cpb was re-initiated.The time off cpb was about 2 minutes and so the delay in the surgical procedure was 2 minutes.There were no other issues the remainder of the procedure.The case was completed successfully, with a 2 minute delay in the surgical procedure as the arterial pump was changed out.There was no associated blood loss and no harm was observed.
|