Description of Event or Problem · 0
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A PATIENT CODED DURING A TREATMENT WITH A DIALOG+ DIALYSIS MACHINE AND PASSED AWAY. AS PER FACILITY POLICY THE CUSTOMER REQUESTED AN EVALUATION OF THE DIALYSIS MACHINE BY THE MANUFACTURER. THE FEMALE PATIENT WAS A 74 YEAR OLD WITH A HISTORY OF HYPERTENSION, DIABETES, AND END-STAGE RENAL DISEASE PRESENTED DUE TO GENERALIZED WEAKNESS AND ELEVATED BLOOD PRESSURE. DURING LIVER FUNCTION TESTS (LFTS) INCREASED PARAMETERS WERE NOTED. SHE WAS EVENTUALLY FOUND TO HAVE ACUTE CHOLECYSTITIS AND UNDERWENT SURGERY ON JULY 12TH. THE PATIENT WAS ON DIALYSIS FOR 2.5 HOURS. SHE WAS LETHARGIC BUT AROUSABLE AND CONVERSANT WITH A BLOOD PRESSURE OF 118/60 AT 20:25. AT 20:55 THE STAFF WAS UNABLE TO OBTAIN A BLOOD PRESSURE AND THE PATIENT WAS UNRESPONSIVE WITH SHALLOW AND SLOW RESPIRATORY RATE. THE STAFF AUSCULTATED A FAINT HEARTBEAT. THE PATIENT WAS PLACE IN TRENDELENBURG POSITION, TREATMENT WAS STOPPED, AND HER BLOOD WAS RETURNED TO HER ALONG WITH AN ADDITION OF 200 ML NORMAL SALINE. RRT WAS CALLED. RRT WAS ALSO ABLE TO AUSCULTATE A FAINT HEARTBEAT. PATIENT WAS AN ALLOW NATURAL DEATH, SO CPR WAS NOT INITIATED. CAUSE OF DEATH: CARDIOPULMONARY ARREST. THE DIALOG+ MACHINE WAS USED FOR 2 TO 3 THERAPIES WITHOUT ANY ISSUE AFTER THE EVENT DESCRIBED ABOVE. IN THE TECHNICAL INSPECTION BY A B. BRAUN ENGINEER DID NOT SHOW ANY MALFUNCTION OF THE DIALOG+ DIALYSIS MACHINE, IT OPERATED AS INTENDED. THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT NUMBER (B)(4).