According to the customer: oxy with lot # 70123613, which was noted to have a similar issue during priming by another nurse.Eventually they were able to get the air out and put the patient on support.Less than 12 hours later, they noted unusual thrombus formation and unusual blood path, this is unknown whether it is related.The circuit was changed without incident.No harm to the patient was reported.While blood priming the venous side of the oxygenator completely blood primed then for an unexplained reason suddenly de primed with air about 1 in down the venous side of the oxygenator.The circuit was eventually completely blood primed, though the venous air at the top of the oxygenator remained.Volume was added to the venous side of the circuit in an attempt to help force the air out.The pt was successfully placed on ecmo and the oxygenator showed no gas exchange issues.Thrombus formation noted in the same areas that the blood prime the previous day was noted to have stagnation.The team felt this amount of thrombos could be a rik for the patient.The oxy was exchanged without issues.Internal reference: (b)(4).
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