A user facility reported a fresenius 2008k2 hemodialysis machine with melted fuses.The fuses were found by a fresenius (b)(4) technician while servicing the machine for an issue where the front panel would not power on.It was confirmed the issue occurred before any treatment, and there was no patient involvement.The technician replaced the melted fuses to resolve the issue and return the machine to service.It was confirmed that no sample parts are available for return to the manufacturer.Additional information was requested, but was not provided.If additional information is received, a supplemental report will be submitted.
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.An on-site evaluation was performed by a fresenius mexico service technician.The technician reportedly replaced the melted fuses to return the machine to service.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.
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