It was reported that the screen of a patient¿s liberty select cycler went blank during their peritoneal dialysis (pd) treatment.The patient reported that there was a burning smell coming from the cycler.The technical support representative advised the patient to disconnect themselves and reboot the cycler.The cycler powered on and the stop and ok buttons lit up, however the screen remained blank.Smoke started coming out of the left side of the cycler.The technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.Upon follow up, the pdrn confirmed that there were no adverse events or medical intervention required as a result of the reported event.The pdrn stated that the patient completed treatment using continuous ambulatory peritoneal dialysis (capd).Additional information was requested but has not been received.
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Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An exterior visual inspection of the returned cycler showed no signs of physical damage.A burning smell was identified when turning on the cycler.Upon power up, the cycler touch screen test failed.When powering on the cycler, the ok, stop and up/down arrow push buttons illuminated, however the front panel touch screen remained blank.It was identified that the cause for the blank screen was due to a burnt transformer (t1) on the inverter board.The inverter board is located on the rear of the touch screen.A known good inverter board was installed and the display became fully operational.A simulated treatment was performed and completed without failure.An internal visual inspection of the returned cycler encountered no other discrepancies.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, the reported issue was confirmed and the cause was determined to be a burnt transformer on the inverter board.The cycler was refurbished following the evaluation.
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