(b)(4).Additional incident information was requested, but not yet provided.A trackwise trend search was performed for p/n 70105.0330, failure code: clotting and no similar incident was found.A sap trend search was performed for p/n 70105.0330, failure code clotting, (b)(4) similar complaints were found out of period 04/2011 to 12/2013, no additional complaints found starting from afterwards until now (2016-10-17).Due to this information no systemic issue could be determined.Clotting is a known phenomenon and has been investigated in a previous complaint.Based on a previous complaint investigation the cause of this failure was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.Dhr review: no oxygenator serial number was provided up to date, therefore a dhr review of the product in question was not possible at this time.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.
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