A user facility reported a fresenius 2008k2 machine with melted fuses.The melted fuses were found by a fresenius (b)(4) technician who was servicing the machine for not powering on prior to treatment.It was confirmed that there was no patient involvement.The technician reportedly replaced the melted fuses to resolve the issue and return the machine to service.It was confirmed that no parts were 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, who reportedly replaced the melted fuses to resolve the issue and 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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