A user facility nurse reported that during recirculation on a fresenius 2008k@home, backflow of dialysate to the saline bag occurs which causes the bag to overfill.Complete verification of the machine was performed, and no problems were found.The issue is known; however, the modification is not done due to the hospital¿s decline of cbe upgrade.The issue occurs approximately 50% of treatment.The patient¿s treatment was discontinued and restarted.Additional information was requested, however to date not provided.
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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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