This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#617147.No problem or issues were identified during the device history record review.No causes or potential causes of the customers reported problem were found during the review of the service and repair records.A product sample was received for evaluation.Visual inspection showed labels were intact.During functional check, the reported complaint was duplicated.Running three accuracy tests, the pump was found to be over delivering to the manufacturing specifications instead under delivery.Found fluid ingression on pump by chassis base of the expulsor, which possibly damaged the gasket and caused an inconsistent delivery issue.Expulsor assembly was replaced.The root cause was attributed to user error/handling.
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