Manufacturer's investigation conclusion: evaluation of the returned oxygenator by the external manufacturer (eurosets) confirmed an oxygenator leak due to fiber breakage; however, a specific root cause for the fiber breakage could not be conclusively determined through this evaluation.The eurosets oxygenator, lot number 7559308, was returned to abbott where an initial visual inspection was performed.Caps were present on the gas inlet and outlet ports and the purge line was connected to its port.Visual inspection of the oxygenator revealed no obvious damage to the external housing, ports, or fibers.A few small droplets of clear liquid were observed within the top orange housing.The oxygenator was forwarded to eurosets for technical analysis.The oxygenator was set up in a circuit with a 500-milliliter reservoir of water and peristaltic pump.The oxygenator was filled with water via the peristaltic pump, and the water was circulated through the oxygenator at a flow of 6 liters per minute (lpm) for 10 minutes.A slow dripping was noticed in front of the blood outlet port.To identify the point of leakage, the device was sectioned by removing the lower housing, refilled with water, and then pressurized.The root cause of the leak was determined to be fiber breakage of the last winding of the fibers at the blood outlet port.The production documentation for the oxygenator lot was reviewed by eurosets and showed that all tests from the production process were compliant with the technical specifications.Devices are required to pass manufacturing inspections and specifications prior to release and no abnormalities were documented which would cause or contribute to the reported occurrence.This device passed all required testing.Eurosets confirmed that 100% of the oxygenators produced are tested to detect eventual leakages using a pressure of 150 kpa (kilopascals) which is 1.5 times the maximum blood pathway pressure indicated on the ifu (instructions for use).Devices that exhibit leaks are discarded prior to distribution.Eurosets determined that the issue occurred after eurosets¿ manufacturing and test phases.The eurosets amg (advanced membrane gas exchange) pmp (polymethylpentene) ifu warns that the extracorporeal circulation always has to be carefully and continuously checked.This document additionally states that a spare oxygenator must always be available during perfusion.If particular situations occur which may lead the person responsible for perfusion to determine that the safety of the patient may be compromised (including leaks), oxygenator replacement should be performed per the ifu guidelines.The production documentation for amg pmp oxygenator, lot number 7559308, was reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.The eurosets amg pmp instructions for use (ifu) is currently available.Under the list of warnings, the ifu warns that during use, a spare oxygenator must always be available and also warns that the device has to be carefully and continuously checked by qualified healthcare professionals throughout the procedure.Also, under the section titled ¿set up¿, the ifu warns to ¿carry out a visual inspection and carefully check the device before use.Transport and/or storage conditions other than those prescribed may have caused damage to the device.¿ under the section titled ¿oxygenator replacement¿, this document states that a spare oxygenator must always be available during perfusion.After 6 hours of use with blood or if particular situations occur, which may lead the person responsible for perfusion to determine the safety of the patient may be compromised (insufficient oxygenator performance, leaks, abnormal blood parameters, etc.), follow the procedure outlined in the ifu for oxygenator replacement.No further information was provided.The manufacturer is closing the file on this event.
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