A peritoneal dialysis nurse contacted technical services to report a patients cycler alarms.Treatment data was provided.Treatment data was assessed for 150% and 180% iipv and did reveal an episode of increased intraperitoneal volume (iipv) on (b)(6) 2018.The largest drain volume from this treatment occurred during drain 2 where 5346ml drained.This drain is 266% of the prescribed fill volume.In order to be a reportable malfunction, at least 180% of the prescribed fill volume would have to have been drained.A 180% of fill volume 2004ml is 3607.Therefore, a reportable malfunction has occurred.Follow up with the peritoneal dialysis nurse confirmed the patient experienced pain, no additional complications were experienced.No treatments were reported missed.The patient has received the replacement cycler, and resumed treatment without further issue.The patient does perform a daytime exchange.
|
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.A simulated therapy was initiated and completed on the cycler without complication.The weighed fill volumes were found to be within tolerance and fill times were within specification.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.A patient sensor calibration test was also performed and the cycler was found to be within tolerance.Load cell verification testing was performed with no issues noted.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, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.
|