The site communicated that the patient was a covid positive patient, had been on centrimag/ amg for nine days with normal performance.Team changed out oxygenator to new amg.Within 30 minutes of oxygenator exchange, post gas showed po2 of 235 then an hour after, 92.8.The site changed it out again and the new oxygenator was performing correctly.
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Manufacturer's investigation conclusion: the report of insufficient gas exchange could not be confirmed as the device is not available for investigation.It was reported that due to the patient¿s covid diagnosis, the eurosets amg pmp oxygenator, lot number 5969906, would not be returned for evaluation.The production documentation for amg pmp oxygenator, lot number 5969906, was reviewed by the external manufacturer 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 section titled, ¿intended use¿, the ifu states that the ¿a.M.G.Module pmp no t.P.Sterile is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours¿ and also that the device ¿is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.Contact with blood for a longer period of time is unadvisable.¿.Under the list of warnings, the ifu warns that during the extracorporeal circulation (ecc) a backup oxygenator is necessary and also wants that the extracorporeal circulation has to be carefully and continuously checked.Under the section titled, ¿bypass start¿, the ifu contains a subsection on blood gas monitoring and explains how to adjust the relevant parameters based on the patient¿s blood gas values.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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