On (b)(6)-2015, information was received from health care provider via a representative that in the past, approximately a year ago, the error code "08" had occurred and there was difficulty with telemetry and communicating with the pumps.The code had appeared during the update and the infusion mode went to "stopped pump." the specific troubleshooting and resolution were not provided but might have been similar to turning the programmer on and off to resolve the issue.There were no patient symptoms or therapy issues.The medication, concentration, dose, lot number, medical history, and concomitant medications were not provided and reported as unknown.The pump involved was not known and the programmer was not being returned.Additional information was requested to verify the patient medication details, indications for use, and specific reason for the incomplete telemetry stopped pump.Should additional information be received a supplemental report will be filed.
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