Udi: unknown part number, attempts to obtain product were unsuccessful, udi unavailable.Attempts are being made to obtain additional information.Upon receipt of new relevant information, a follow-up report will be submitted.
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The device was returned for evaluation.The position of the cam when the valve was received was 4.The valve was visually inspected; biological debris was noted in the valve mechanism and needle holes in the needle chamber were noted.The valve was tested for programming and failed.The valve was flushed; no occlusions were noted.The valve was leak tested, only leaked from the needle holes in the needle chamber.The valve was reflux tested and failed.The valve was dried.The valve was pressure tested at setting 4, the valve failed.Biological debris was found on the ruby ball, on the flat spring of the cam/ball arm assembly, on the rotating construct, on the magnets and on the helical spring.A review of manufacturing records was not possible as the lot number was unknown.Based on the results of the investigation, the reported issue is confirmed.The root cause for the problems found during investigation is due to the biological debris found on the ruby ball, on the flat spring of cam / ball arm assembly, on the rotating construct, on the magnets and on the helical spring.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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