It was reported that when the patient was placed on the tandemlife oxygenator, support was initiated with flows of approximately 3 liters per minute, but shortly after initial flows began to drop to 1 liter per minute.Above 300 mmhg.Standard troubleshooting was performed, and the oxygenator pressure drop was elevated.The oxygenator was changed out and support was continued without issue with the new oxygenator.Device history review did not identify any deviations or non-conformities relevant to the reported issue.The device was received for product analysis.The returned device showed evidence of thrombus in the bundle, which may have developed during support or shipment from residual blood left in the device.The elevated pressure drop was consistent with what was reported by the site.The drop in flow was likely caused by thrombus developing in the fiber bundle.Sectioning the device showed deposits in the central fiber layers which were evidence of the presence of a thrombus.It was unclear if the thrombus had formed either during the case or from residual blood left in the device after the device was changed out and sent back for analysis.It was noted that thrombus layers in the center layers of fiber can have a large effect on the pressure drop.The root cause of the pressure drop was unable to be definitively determined, however it appeared likely that the presence of a thrombus in the oxygenator caused the flow issues reported during use of the device.No additional or relevant information has been received to date.
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