A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a wire between the rocker switch and the power control board that burned and melted.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 biomed did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the wire.The machine has approximately 11,000 hours and the wire was the original fresenius parts on the machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burned and melted wire.The biomed replaced the rocker switch and melted wire, which resolved the issue.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The parts were discarded by the biomed and are not available to be returned to the manufacturer for physical evaluation.
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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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