This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#617147.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 missing sticker seal.During functional check, the reported problem not duplicated.Performed no disposable alarm testing of pump as per procedure.However, running three accuracy tests, the pump was found to be over delivering instead of under delivering to the manufacturing specifications.Checked the returning communication module and it was defective.Trimmed expulsor down to bring the delivery accuracy closer to nominal of a range and customer purchased a new communication module.
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