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 04/24/2019 |
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 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.An internal visual inspection of the returned cycler encountered no other discrepancies.The treatment was cancelled.The cycler was powered ¿off¿ and ¿on¿ during a simulated treatment and the ¿power fail recovery¿ performed as intended.The simulated treatment resumed after the power interruption and completed without any failures or problems.In addition; the cassette insert and removal check passed.Safety clamp test passed.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process related to the reported symptom code(s).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 on 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 a patient¿s liberty select cycler displayed a blank screen during drain number two of four of their peritoneal dialysis (pd) treatment.The outlet was functional and the ok and stop key lights were illuminated.Three different outlets were utilized; however, upon rebooting the cycler the screen remained blank and an unknown alarm was observed.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.Upon follow up, the pdrn confirmed the patient was training at the clinic and was unable to complete treatment, and there was no medical intervention required.The cycler was returned to the manufacturer and a replacement cycler was provided and received.Upon physical evaluation of the cycler by the manufacturer, there was evidence of an internal short which was identified on the transformer on the inverter board.
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