Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed. A batch records review was conducted by the manufacturer for the reported lot. There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event. The entire lot has been sold and distributed. In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements. The lot met all specifications for release. A product history review did not reveal a probable cause for the customer complaint. As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
It was reported that a peritoneal dialysis (pd) patient encountered a fluid leak from the connection of the adapter to the solution bag during an unknown phase after drain 0 of pd treatment. It is unknown at which point in therapy the leak may have begun. There was no fluid leak observed within the cycler. The patient was advised by the peritoneal dialysis registered nurse (pdrn) to re-setup supplies. Upon follow up, the pdrn is unsure what caused the fluid leak. The patient was able to resolve the issue by further tightening the connection, however, the pdrn advised the patient to re-setup supplies. The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event. The cassette used by the patient was discarded and is not available to return for physical evaluation by the manufacturer.
Patient Sequence No: 1, Text Type: D, B5