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 and did not notice any external damage.A review of the event history log identified there was a clutch error in history.Customer stated problem was verified during occlusion tests.The reported issue was replicated, the root cause was the right plunger case was not set properly onto the timing pates.The tech reassembled plunger head to resolve the issue.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product information has been provided to date.
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