A user facility biomedical technician (biomed) reported that a 2008t machine experienced a flow error during setup.The biomed stated that valve 34, on the balancing chamber, looked burnt.The biomed also reported that a burning scent was noticed.There was no smoke, melting, or arcing noted, and there were no reports of sparks or flames.No damage was identified on any other components.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test.The biomed replaced the burnt valve to resolve the reported issue.Prior to replacing the burnt valve, the biomed had swapped the flow motor, the deaeration motor, the diasafe plus filter, and the actuator test board.Upon follow up with the biomed, it was confirmed the machine was returned to service and has not experienced any further issues.The burnt valve was not available to be returned for evaluation as it was reportedly discarded.There was no patient involvement associated with the reported event.
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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