A user facility biomedical technician (biomed) reported a fresenius 2008k2 machine with a flow inlet error during rinse mode.It was confirmed that there was no patient involvement.While inspecting the machine for repair, the biomed reported that the plastic housing of the deaeration motor had melted around the deaeration motor brushed.It was confirmed there was no observed burning smell, smoke, spark, flame, or arcing, and it was confirmed there was no patient involvement.The machine reportedly has 18,345 hours of use on it, and had not had past issued failing the electrical leakage test.The machine is plugged into a gfci outlet.The biomed confirmed he replaced the deaeration motor to resolve the issue and return the machine to service.It was confirmed that photographs of the damage were not available, and confirmed that there were no sample parts available for return.
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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 regional equipment specialist (res).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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