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.An internal inspection of the cycler found transformer (t1) on the inverter board to have internal short.The inverter board is located on the rear of the touch screen.A known good inverter board was installed, and the touch screen became operational.Removed functioning inverter board 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 an internal short 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 drain 4 of their peritoneal dialysis (pd) treatment.The wall outlet was working.The ok and stop keys were on and the cycler was rebooted; 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.Upon follow up, the pdrn confirmed that there were no adverse events or medical intervention required as a result of the reported event.The patient did not complete treatment.The cycler was returned to the manufacturer and a replacement cycler was provided and received.The patient has resumed treatments on the new cycler.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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