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 on the 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.The functioning inverter board was removed 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 an internal short of the transformer on the inverter board.The cycler was refurbished following the evaluation.
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A peritoneal dialysis registered nurse (pdrn) contacted fresenius technical support to report that the liberty select cycler experienced can't turn on cycler alarm during of setup.The ok and stop key do not make any sound when pressed.The fresenius technical support representative issued a replacement cycler and advised the pdrn to discontinue using the machine.Additional information was requested but to date, has not been provided.The cycler was returned to the manufacturer.Upon physical evaluation of the cycler by the manufacturer, it was identified that the transformer on the inverter board had an internal short.
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