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.The ¿go/ no go gauge¿ check passed.The load cell verification passed.There were visual indications of dried fluid underneath the cassette compartment during the internal inspection.No burrs or sharps in cassette area that may have punctured a cassette membrane.The cause of the observed dried fluid could not be determined.There were no other discrepancies during the internal inspection of the returned cycler.The cycler tested negative 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 found a prior occurrence of a blank screen.The failure analysis problem report indicated the inverter board was faulty.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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It was reported that the screen of a patient¿s liberty select cycler went blank after ending their peritoneal dialysis (pd) treatment.The patient also stated that the cycler had an unknown alarm during treatment.The power cord was plugged into a working outlet.The ok and stop keys were on, however the screen remained blank.Rebooting the cycler did not restore display.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 was able to complete treatment using manuals.The cycler was returned to the manufacturer and a replacement cycler was provided and received.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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