Sorin group italia manufactures the d903 avant 2 phisio coated oxygenator.The incident occurred in edmonton, canada.Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).The involved device was returned to sorin group italia for investigation.During visual inspection, no visible defects were noted.The device was tested in order to evaluate the pressure drop in standard conditions.No device malfunction was identified during this testing.The device was found to be conforming to manufacturer specifications.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As the issue could not be reproduced, a root cause was not determined.However, one possible root cause is transient undesired cellular activation.This root cause is multi-factorial in nature and not device specific.
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