A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The unit was requested back to the manufacturer site for investigation.The device was tested for pressure drop and results revealed no deviation and revealed that the device was performing according to manufacturer specifications.A gas leak test was conducted the end cap of the oxygenator became separated at the bond joint.Based on the current level of information, the exact root cause of the event could not be established.However, based on the fact that gas leak test are conducted at 100% during manufacturing, it cannot be excluded that a transportation issue may have compromised the oxygenator integrity.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|