A user facility biomedical technician (bmt) reported that a 2008k2 hemodialysis (hd) machine experienced a saline bag backfill during the setup (prime) process in dialysis mode.
The bmt stated there is an air separator adapter board installed on this machine.
The bmt verified there was no patient involvement associated with the reported issues.
Upon further inspection of the machine, the bmt discovered that one of the ball bearings in the arterial hansen connector was missing.
This was generating blockage on the arterial side of the dialysate, and effectively pushing the saline back into the bag.
The machine was in the setup process in dialysis mode when this occurred.
User error was not a contributing factor.
The machine had over 50,000 hours on it at the time of the event.
The machine did not give any filling programs.
The bmt confirmed the machine had upgrades for the changes being effected (cbe) completed, and verified that the drain line length and height were within specification.
A quick disconnect is reportedly used on the drain line.
To resolve the reported issue, the bmt replaced the air separator chamber and the arterial hansen connector.
The machine was subsequently returned to service.
The used parts were not available to be returned for evaluation.
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