CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number RTLR180343 |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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.Upon power up, the cycler touch screen test failed.When powering on the cycler the front panel touch screen appeared blank.It was identified that the cause for the blank screen was due to an internal short present on a transformer of the inverter board.The inverter board is located on the rear of the touch screen.A known good inverter board was installed and the cycler passed a functional/display test.There were no other discrepancies during the internal inspection of the returned cycler.The cycler underwent and passed a system air leak test and a valve actuation test.A fifteen minute self test and simulated treatment completed without an failures.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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Event Description
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It was reported that the screen of a patient¿s liberty select cycler went blank during an unknown phase of their peritoneal dialysis (pd) treatment.The power cord was properly connected into a wall outlet.Rebooting the cycler did not restore the display.The ok and stop keys were on, 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, it was confirmed that there were no adverse events or medical intervention required as a result of the reported event.The patient completed treatment on the date of the event.Upon physical evaluation of the cycler by the manufacturer, evidence of an internal short on the transformer on the inverter board was identified.
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