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 05/08/2019 |
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.The reported burning smell was confirmed.Upon power up, the cycler touch screen test failed.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 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 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 a peritoneal dialysis patient noticed a burning smell while in set up after placing the heater bag on the heater tray.The patient reported that the display went blank and smoke was smelled.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.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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Manufacturer Narrative
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Correction: date of event should be (b)(6) 2019.
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Search Alerts/Recalls
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