It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the occlusion backed off and the perfusionist had to manually occlude the pump.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Pre clinical review: per the customer, during a procedure the perfusionist (ccp) was in the process of going down on flow for cross-clamp placement.While he was going up to release the vacuum, he accidently hit the arterial roller head with his wrist.The movement knocked the occlusion cap off and he heard a zip sound, and lost all occlusion in the arterial 6 inch roller head.(preventive maintenance (pm) had just been done the day prior on this pump) when the ccp came back up on flow from going down on flow for cross-clamp placement, he stated that is was very obvious that he had lost all occlusion on the arterial head.He proceeded to quickly reocclude the arterial head, and stated that the patient's blood pressure was low for approximately 10 seconds.He noted that he was able to re-occlude the head without issue, but he may have over-occluded it at that moment, because of his need to quickly get back to a normal flow for the patient.He was able to flow at set occlusion and flow the remainder of the procedure.He also did say there was no apparent hemolysis of the red cells due to the nature that his re-occlusion may have been tighter than previously set.The incident did not delay the continuation of the surgical procedure, and the patient was weaned from bypass without issue.There was no blood loss nor any harm observed.
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