Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The product was disposed by the hospital; therefore a manufacturer laboratory investigation was not possible.A review for similar complaints with a product lab investigation performed was done and the following results could be obtained: the product was visual inspected in the lab of the manufacturer.Some clotted areas were visible on the outlet and inlet side.No clots were rinsed out during cleaning.The product was tested with bovine blood in the laboratory of the manufacturer for its o2, co2 transfer rate as well as for its pressure drop behavior at maximum flow.The product was operating according to the acceptance criteria's and therefore passed the test successfully.Clotting is a known phenomenon to mcp and the cause of this incident was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time, the oxygenator in question operated within mcp specifications.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.
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