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 06/19/2019 |
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 loud cell verification test was performed and failed due to heater tray cables resign on the power supply assembly.The heater cable was adjusted and the load cell verification test passed.An internal visual inspection of the returned cycler encountered no other discrepancies.A device history record (dhr) review was performed found a prior occurrence of dim, distorted, or blank screen.A production floor problem report indicated that the failure was due to a defective inverter board.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 patient¿s liberty select cycler went blank during their peritoneal dialysis (pd) treatment.The patient reported that they received an invalid sensor reading warning during drain two of three, and rebooted the cycler.The screen would not turn on after reboot.The patient checked the cord and rebooted the cycler, however the screen remained blank.The cycler was properly plugged into the socket.The ok and stop keys were on, however the screen remained blank.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.Upon follow up, the patient confirmed that there were no adverse events or medical intervention required as a result of the reported event.The patient was able to complete treatment with manual exchanges.The cycler was returned to the manufacturer and a replacement cycler was provided and 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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