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 04/29/2019 |
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 touch screen test failed and upon power up, the ok, stop and up/down arrows 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 touch screen became fully operational.The functioning inverter board was removed from the touch screen at the completion of the investigation.An internal visual inspection of the returned cycler encountered no other discrepancies.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 the screen of a patient¿s liberty select cycler went blank during preparation for their peritoneal dialysis (pd) treatment.The ok, and stop keys were illuminated and the outlet the cycler was plugged into was working.Rebooting the cycler did not restore the display.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.It was reported that an alternate treatment option was not available.The cycler was returned to the manufacturer.Should additional information become available, the file will be reassessed and updated accordingly.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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