Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed no signs of physical damage.The touch screen test failed - when powering on the cycler the ¿ok, stop, and up/down arrows push buttons¿ illuminated, however the front panel touch screen remained blank.An internal inspection of the cycler found evidence of an internal short present on transformer (t1) of the ¿inverter board¿.The inverter board is located on the rear of the front panel assembly.A burn smell was also encountered during the internal inspection.The smell was due to the thermal decomposition of the transformer (t1) of the ¿inverter board¿.A known good inverter board was installed and the touch screen became operational.A burn smell did not occur with the known good inverter board installed.The functioning inverter board was removed from the touch screen at the completion of the investigation.There were no other discrepancies encountered in the internal inspection of the cycler.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 shorted transformer on the inverter board.The cycler was refurbished following the evaluation.
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It was reported that the screen of a patient¿s liberty select cycler went blank during their peritoneal dialysis (pd) treatment.The ok and stop keys were on, however the screen remained blank.At that point in time, 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.The patient did not complete treatment.The cycler was returned to the manufacturer and a replacement cycler was provided.Upon physical evaluation of the cycler by the manufacturer, it was identified that the transformer on the inverter board was shorted.
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