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
Abdominal Distention (2601)
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Event Date 05/02/2019 |
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 on transformer (t1) on the inverter board.A known good inverter board was installed and the display became fully operational.The voltage check passed.A simulated treatment was performed and passed.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 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 a patient¿s liberty select cycler powered down during their peritoneal dialysis (pd) treatment.The patient stated that they woke up and felt full, and noticed that the cycler was off.The patient pressed the screen and tried to turn the cycler off and on, however the cycler would not power pack on.The patient stated that there was still power in the house.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.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 was identified on the transformer on the inverter board.
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