Additional information: d9.H3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An exterior visual inspection of the returned cycler showed power entry module (located on the returned cycler¿s rear panel) was damaged.The power-on verification failed.The power cord was inserted to the power entry module and the power switch was set to on, but the cycler did not power on.An internal visual inspection found the spade connectors on the power entry module were disconnected, and the tab connectors were contacting each other.There were visual indications of charring on the power entry module tab connectors.The damaged power entry module was replaced with a known good power entry module to proceed with investigation.The cycler was able to power on.No other discrepancies were found during the internal visual inspection.The catch-post hipot test, the patient hipot test, and the current leakage test were performed and passed.The returned cycler¿s voltage values, current leakage values, and enclosure leakage values were in tolerance for a liberty cycler.An as-received 11500ml cycle-based continuous cyclic peritoneal dialysis (ccpd) simulated treatment was performed and passed without further alarms or issues.The system air leak test, the valve actuation, the voltage check, and the patient pressure sensor calibration check all passed.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.The cycler was refurbished following the evaluation.
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