According to the surgeon, who was responsible for the surgery, a circulatory support system (ecmo) was initiated for a child, immediate postoperative for aortic arch hypoplasia correction of transposition of the great arteries.On the first day of ecmo, the machine couldn't give flow.Suspected presence of thrombus in the oxygenator membrane.The product was exchanged.(b)(4).
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(b)(4).The sample was returned on (b)(6) 2017 and it was investigated in the complaints laboratory at the site in hechingen.During the rinsing of the quadrox-i pediatric, no clots were flushed out.The dhr review showed no deviations.The sample was investigated and the failure could not be confirmed.There was no evidence of a production issue, and the conclusion of the investigation is that the issue is not related to a product-related failure, and the most likely root cause would be related to a clinical or application-related issue.No systemic issue was identified from the complaint database review but the data, however, will continue to be monitored and 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 investigation or action is warranted at this time and the complaint will be closed.
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