This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection showed the bottom case and the plunger assembly were cracked.Unable to go into pump history due to power up problem.During functional testing the reported issue was duplicated.The root cause of this issue was customer induced via fluid ingression into the main body of the pump as a result of either the customer's improper cleaning of the pump, or the customer's introduction of excessive fluids to the pump surface.Replaced main printed circuit board and performed preventative maintenance and all functional testing.
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