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 04/26/2019 |
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.The functional display check failed and a blank screen was encountered.It was identified that the cause for the display brightness problem/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 known good inverter board was installed and the display became fully operational.The cycler underwent and passed the touch screen test, functional/display test, voltage verification test and simulated treatment pre-ast 15 minute 1000 ml test.There were no other discrepancies encountered in the internal inspection of the cycler.A review of the device history record (dhr) did not reveal any issues or problems related to the reported symptom codes.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 was very dim during set up and they could barely see the details on the screen for their peritoneal dialysis (pd) treatment.The cycler was plugged directly into a three prong wall outlet that was not shared.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 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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