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 06/08/2019 |
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 present 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.The cycler underwent and passed a valve actuation test and system air leak test.A fifteen minute self test/treatment was performed and completed without failure or problems.An internal visual inspection of the returned cycler encountered infestation.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 clinic¿s liberty select cycler went blank during drain four of four of a patient¿s peritoneal dialysis (pd) treatment.The power cord was properly connected in both ends.The cycler was rebooted and the ok and stop keys were on, however the screen remained blank.The patient was able to complete treatment.A loud pop noise was also reported.At that point in time, the technical support representative advised to discontinue use of the cycler.A replacement cycler was issued to the clinic.Additional information was requested, however to date 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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