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 Patient Involvement (2645)
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Event Date 04/25/2019 |
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.No unusual noises occurred during power-up.It was identified that the cause for the blank screen was due to an internal short on transformer (t1) of the inverter board.The inverter board is located on the rear of the touch screen.A burn smell was also encountered during the internal inspection.The smell was due to the thermal decomposition of the transformer (t1) of the ¿inverter board¿.A known good inverter board was installed and the display became fully operational.No unusual noises or burn smell occurred with the known good inverter board installed.There were no other discrepancies encountered in the internal inspection of the cycler.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 the transformer of 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 set up of their peritoneal dialysis (pd) treatment.The power outlet was properly working and the ok and stop keys were on, however the screen remained blank.The patient contact also reported that on power up, there was a winding noise coming from the screen.At that point in time, the technical support representative advised the patient contact to discontinue use of the cycler and to notify the patient¿s 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 and upon physical evaluation of the cycler, it was identified that there was an internal short on the transformer of the inverter board.
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