The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.The device was repaired in the field by the clinic biomed technician.A replacement level detector board was ordered and replaced to resolve the reported issue.The device was repaired and returned to service.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.
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Hemodialysis clinic contact reported to technical support encountering a venous pressure alarm during dialysis mode.There was no reported patient complications.The patient was placed on another hemodialysis machine and the dialysis treatment was completed.Additional information was solicited and received.The hemodialysis machine was repaired and put back into service.The patient experienced minor blood loss, 150ml, during the transfer to another hemodialysis machine.There was no medical intervention.
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