It was reported that a peritoneal dialysis registered nurse (pdrn) discovered a spark.The pdrn stated that they disconnected the power cord of the cycler from the wall outlet and saw a spark at the outlet.At that point in time, the technical service representative advised the pdrn to discontinue use of the cycler and issued a new cycler.Upon follow up, the pdrn confirmed that no patient was connected or involvement when the issue occurred.The replacement cycler was received and the new cycler was scheduled to be picked up for return to the manufacturer.
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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.A simulated treatment was performed and completed without failures.The cycler weighed fill volume values were within tolerance for a liberty cycler.The cycler underwent and passed a system air leak, valve actuation, patient hipot safety, and catch post hipot test.The load cell verification was within tolerance.The voltage check failed.The 5 volt displayed and measured values were out-of- specification.The 5 volt measured and displayed were adjusted and the voltage check passed.There were no 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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