(b)(4).Upon completion of the investigation, it was noted that the valve was visually inspected it was noted that the stator and x ray dot are dislodged.Therefore; the cam position/programming and pressure test could not be determined.The valve was hydrated.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, no leaks were noted.The catheter was irrigated, no occlusions were noted.The valve was reflux tested.The valve failed the test.The valve was dried.The valve was dismantled and was examined under microscope at appropriate magnification: a crack and a scratch mark were noted in the valve casing.This is probably due to the valve receiving some form of impact.Corrosion was noted on the stator and the x ray dot.The cam magnets were controlled.The magnets passed.Review of the history device records for the valve, product code 82-3100 with lot p.1284, showed an (b)(4) report when released to stock on the 19th november 1997; the nc report issue had no link to this complaint.The root cause of the corrosion could not be clearly determined.The root causes for the dislodged stator could be partly due to the valve receiving some form of impact, as well as the corrosion, this however could not be determined.Based on the results of this investigation, no further action is required.Trends will be monitored for this and similar complaints.At the present time, this complaint is closed.
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