A biomedical technician (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had a motherboard with a burned capacitor.The burned motherboard was initially found while the machine was out of service.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 reported that there was no damage observed on any other components, or any other additional issues, associated with the burned motherboard.However, it was also reported that the machine alarmed with a conductivity offset error during service mode.The biomed replaced the motherboard, which resolved the burn damage.The machine remains out of service until the arrival of replacement parts for the repair of the conductivity offset error.The motherboard was discarded by the biomed and is 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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