Manufacturer's investigation conclusion: the production documentation for amg pmp oxygenator, lot number 5830806, was reviewed by the external manufacturer and showed that all tests from the production process were compliant with the technical specifications.The report of a blood leak could not be confirmed and no device-related issues were discovered during the evaluation of the returned oxygenator.The eurosets amg pmp oxygenator, lot number 5830806, was returned to abbott and an initial visual inspection was performed.Visual inspection of the oxygenator showed no obvious cracks or damage to the external housing or ports.The oxygenator was then forwarded to the external manufacturer for technical analysis.Upon receipt at eurosets, the oxygenator was cleaned and dried before proceeding with the functional test.The test circuit was filled with physiological water and an initial flow of 4 lpm was established.After 30 minutes of operation, no leaks from the oxygenator were identified.The flow was then increased to the maximum recommended flow of 7 lpm as indicated in the amg module pmp ifu, and a counter pressure at the blood outlet of the oxygenator was applied by partially clamping the connector at the blood outlet of the oxygenator.After 2 hours of operation, no leaks from the oxygenator were identified.Functional testing of the oxygenator revealed no source of leakage and the manufacturer determined that the device was compliant with product specifications.No further information was provided.The manufacturer is closing the file on this event.
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