MDR event

Additional Manufacturer Narrative

ON APRIL 14TH, 2008, FACILITY'S BIOMEDICAL TECHNICIAN RECALIBRATED THE FINAL CONDUCTIVITY, PERFORMED A PA AUTOCALIBRATION AND A T1 TEST. A GAMBRO TECHNICIAN INSPECTED THE PHOENIX MACHINE ON APRIL 22ND, 2008. ALL THE PARAMETERS WERE WITHIN MANUFACTURER'S SPECIFICATIONS. THE TECHNICIAN PROACTIVELY REPLACED THE A CONDUCTIVITY PROBE AND THE PA CONCENTRATE PUMP. FROM THE AVAILABLE DATA IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE THAT LED TO THE REPORTED EVENT. A TECHNICAL INVESTIGATION IS IN PROGRESS AT GAMBRO DASCO. SHOULD SIGNIFICANT NEW INFO BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.