It was reported that the connectors for the acid and bic pump show signs of heat (melted) on the hemodialysis (hd) machine.Upon follow-up with the biomedical technician (biomed), it was reported the issue was discovered at an unknown time.There was no burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage found related to the melted connectors.The machine had approximately 19,345 hours and that the distribution board is the original fresenius part.There was some discoloration on the distribution board.The biomed stated that the distribution board and bicarb pumps were replaced but the machine was not back in service.There was no damage observed on any other components or any additional issues.The biomed confirmed that a patient was not connected to the machine at the time of the event and there was no harm to any patients or any individuals because of the issue.The biomed confirmed that no parts are available to be returned to the manufacturer for evaluation because they were discarded.
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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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