A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a burned power cord.The burned power cord was noticed during daily setup.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The cord was the original fresenius part on the machine.The biomed reported that there was no melting, burning smell, smoke, spark, flame, or arcing observed.The biomed reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components.The machine has approximately 12,000 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed replaced the plug, which resolved the issue.The biomed reported that the machine has been returned to service without issue.The power plug was reported have been discarded and is not available for manufacturer evaluation.
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Additional plant investigation information: 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.
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