Trackwise id (b)(4).Updated section: b-4,e-3, g-3, g-4, g-7, h-2, h-6,h-10-h11.Corrected section: h-6 problem code from 4042 to 1669.The lot # 25162814 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.The device was not returned to maquet cardiac surgery for investigation, therefore no evaluation could be performed.It is not possible to confirm the reported complaint.
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