A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICE REGARDING A TINA HEMODIALYSIS INSTRUMENT. THE HOME PATIENT (HP) STATED THAT THE MACHINE IS PULLING OFF TOO MUCH FLUID DURING PATIENT USE. THE PATIENT REPORTED TWO INCIDENCES IN 2009. ON THE SECOND DAY, THE MACHINE WAS PROGRAMMED TO REMOVE ONE POUND OF FLUID IN SIX HOURS AND THE MACHINE REMOVED TWO POUNDS OF FLUID IN ONE HOUR. HE STATED HE HAD TO TERMINATE TREATMENT BOTH DATES AND HE COULD NOT RETURN THE BLOOD IN THE TUBING SET, SO HE LOST 200-300 CC'S. THE HP DID NOT RESTART TREATMENT AFTER THESE INCIDENTS. HE STATED THERE WAS NO INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH PULLING OFF TOO MUCH FLUID. DURING FOLLOW UP, THE HP STATED THAT THE MACHINE HAD BEEN FAILING SELF-TEST AND THAT THE FLOW EQUALIZER WAS MALFUNCTIONING. THE HP ALSO REPORTED THAT THE DIALYZER WAS CLOTTING OFF AND PER THE HP THIS WAS A RESULT OF THE FLOW EQUALIZER ISSUE.
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Patient 1
IN 2009, A FIELD SERVICE ENGINEER (FSE) WENT TO THE HP'S HOME, EVALUATED THE DEVICE AND CONFIRMED THE PROBLEM. THE FSE REPLACED THE BYPASS VALVE, ALL VALVES, THE DIAPHRAGMS, THE O-RINGS ON THE FLOW EQUALIZER, AND THE END OF STROKE SENSORS (EOS). THE FSE CALIBRATED THE TEMPERATURE, THE CONDUCTIVITY, THE ULTRAFILTRATION (UF) FLOW RATE, THE DIALYSATE FLOW RATE AND THE DIALYSATE PRESSURE. THE FSE INSPECTED AND TESTED THE MACHINE AND ALL SYSTEMS PASSED. THE FSE RAN A MOCK TREATMENT AND CHECKED VOLUME AND THIS WAS ACCURATE. MACHINE WAS RELEASED FOR USE BY THE PATIENT.