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.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 an internal short present 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.There was visual evidence of dried fluid found within the cassette compartment.There were no visually indication of particulates within the cassette area.There were no burrs or sharp edges in the cassette area that may have punctured a cassette membrane.There was visual evidence of dried fluid within the recess of the bottom cover adjacent to the pump.The cause of the observed dried fluid could not be determined.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.The cycler tested positive for glucose 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 an internal short on transformer on the inverter board.The cycler was refurbished following the evaluation.
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It was reported that there was a burning, electrical smell from a patient¿s liberty select cycler during dwell three of four of their peritoneal dialysis (pd) treatment.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.It was reported that an alternate treatment option was available.Upon follow up, the patient confirmed that there were no adverse events or medical intervention required as a result of the reported event.The patient was able complete treatment with manual exchanges.The patient confirmed that there was no visibly burnt component.The patient stated that the cycler screen was blank.The cycler was returned to the manufacturer and a replacement cycler was provided and received.Upon physical evaluation of the cycler by the manufacturer, evidence of an internal short on the transformer on the inverter board was identified.
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