This is a report of a patient who experienced an increased intraperitoneal volume (iipv) event coincident with peritoneal dialysis (pd) therapy.The event was discovered while reviewing the patient¿s treatment records following a report of a patient having a supply bag lines are blocked alarm during dwell 2 of treatment.The patient also stated that when they were trying to cancel out this treatment, the cycler would resume treatment when the cancel option was pressed.The patient discontinued treatment during cycle 2 due to the large drain.A review of the patient¿s treatment records identified that the patient drained 2372 ml during drain 1 of the treatment.This drain volume is 182% the patient's prescribed fill volume of 1300 ml.It was reported that the patient was going to try to use the cycler the next night.Upon follow up with the peritoneal dialysis registered nurse (pdrn), it was confirmed that the patient did not experience any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd).
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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