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 06/27/2019 |
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.The cycler gave an audible alarm.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.A pre- accelerated stress test (ast) of simulated treatment with 1000ml for 15 minutes was completed without failures.After restarting the cycler a power fail recover alarm appeared.Treatment resumed without failure.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 identified a prior occurrence on (b)(6) 2019 of a dim, distorted, blank screen caused by a defective lcd display.No other discrepancies were identified in the dhr and there were no other deviations or non-conformances during the manufacturing process.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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The contact of a peritoneal dialysis (pd) patient contacted fresenius technical support to report that the screen went blank on the liberty select cycler while the cycler displayed the power fail recovery failed screen.The patient contact reported that they were originally calling about the power fail recovery failed screen and wanted to know why they could not press resume 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.Additional information was requested, however, to date a response has not been received.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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