CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Model Number 180343 |
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 03/17/2020 |
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.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 present transformer (t1) on the inverter board.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.A pre-accelerated stress test 15-minute 1000 ml simulated treatment was performed and completed with no 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 on 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 ok and stop keys were pressed, the touch screen was touched, but the screen remained blank.The ok and stop keys made a sound when pressed, the cycler was rebooted, the ok and stops keys illuminated, but 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 has not been provided.The cycler was returned to the manufacturer.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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