A biomedical engineer (biomed) at a user facility reported that the fresenius 2008t hemodialysis (hd) machine had a discolored power plug which was observed during preventative maintenance or servicing the machine unrelated to the plug.The inside of the plastic casing of the plug was reportedly melted and charred.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 event.The biomed reported that there was no smoke, spark or flame observed.The biomed replaced the power plug assembly, which resolved the issue.The unit was returned to service at the user facility without a recurrence of the event as reported.No parts are 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 of the unit was performed by a fresenius regional equipment specialist (res).The reported melted and charred power plug was replaced by the biomedical technician (biomed) to resolve the issue.Following parts replacement, the unit was returned to service at the user facility without a recurrence of the event as reported.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 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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