ARTIS/EVOSYS DIALYSIS SYSTEM 에 대한 현장 안전성 서한

Field Safety Notice

2016-07-20

Slovenia

AMPMDRS

Baxter distributed an f sn (ref. annex 1 fsn fa—2014—010) in december 2014 to advise the user of the possibility that foam may have formed in the venous blood line when the extracorporeal circuit was primed using on—line priming. the f sn provided additional information on how to perform priming in case the specific dialyzer in use generates foam in the venous chamber. the number of reports of foam in the venous chamber significantly decreased with the application offsn fa-2014—010 recommendation as a collateral effect of the same problem, i.E. residual air and foam after priming, it has been observed an increased probability of air alarms occurrence. it has to be clarified that air alarm is not a risk in itself and is intended to prevent infusion of air which might be dangerous to the patient. this alarm stops the blood pump and interrupts the treatment until resolution by the user. in some cases it was reported that a few minutes after resolving an occurrence of air alarm and restarting the blood pump the patient experienced symptoms commonly repofied as hypotension. this typically followed a prolonged blood pump stop associated to a problematic air alarm troubleshooting.