A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed the tamper seal were removed.No backlight,hand written sn on label also very old worn drive train parts.A review of the event history log identified occlusion and checked infusion line.Techs performed occlusion test, check the reading of force sensor.Testing was unable to duplicate the premature occlusion, pump was occluded when the pressure build up, and all the reading of force sensor is within the required specs.No problem was found, pump operated as intended.Who caused the reported problem: no problem was found, pump operated as intended, therefore no root cause could be determined.Performed pm maintenance and all functional tests.Repair was not needed for customer reported problem due to no problem was found.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
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