Udi no.Not required for this product code.The actual device was returned to the manufacturing facility for evaluation.Visual inspection did not find any anomalies in the appearance.A leak in the purge line was confirmed.Magnifying inspection of the leak found that the tube had a tear which reached the lumen.Electron microscopic inspection of the leak revealed that the cross section of the torn tube was in the smooth state with the generation of some streak going inward, indicating that the tear had developed in the inward direction.The customer stated that they may have hit the purge line with forceps during the priming stage.The following simulation tests were conducted.The purge line connected to the oxygenator was hit with forceps 10 times.Water was filled in the test sample for any observation of a leak.No leak occurred.The result of a hitting force with forceps alone was not confirmed to cause a leak at the purge line.Another simulation test was conducted.The test sample was cooled down to 4 °c and then the purge line was subjected to a shock force.The purge line tube became torn.Electron microscopic inspection of the tear cross section revealed that it was in the smooth state with the generation of some streaks starting from the point the shock force had been applied and spreading inward, similar to the state of the tear on the actual sample.A review of the device history record and product release decision control sheet of the involved product code/lot# combination was conducted with no relevant findings.A search of the complaint file found no other report with the product code/lot# combination.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information, however, it is likely that the purge line tube of the actual sample became torn partially by being exposed to an instantaneous shock force.Subsequently, when the actual sample was subjected to additional forces the tear further-developed resulting in the reported leak.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx15 oxygenator and reservoir." (b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
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