The rapid infuser, fms 2000 has been returned to belmont for investigation.Evaluation of the unit is in process.In the event of an "over temperature" alarm, the fms displays the following alarm message: "infusate over temperature.Discard disposable and blood.Restart system with a new disposable.Service machine if error persists." the operator's manual also provides possible conditions and additional recommended operator actions.When the fms detects a situation that is compromising effective infusing, the system stops pumping and heating, closes off the line to the patient, sounds an audible alarm, and displays an alarm message with instructions for corrective measure.It was reported that the disposable set was discarded at the hospital, and the user facility was unable to provide the lot number of the disposable set involved.Without results of the investigation, a root cause of the reported alarm cannot be established.The hospital biomed reported that the unit also suffered an accidental drop which resulted in damage to the housing, and that the touch screen is not functioning.There was no patient injury reported.The manufacturing records for this fms serial number were reviewed and no anomalies were identified.The unit has not been returned to belmont for service or preventive maintenance since it was shipped to the customer in 2016.A follow-up report will be submitted upon completion of the investigation.
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