GAMBRO DASCO SPA PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 6023006700 |
Device Problems
Device Displays Incorrect Message (2591); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2022 |
Event Type
malfunction
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Event Description
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Hemodialysis machine was set up correctly and passed all tests.The arterial and venous chambers were filled to the correct level before treatment initiated.Alarmed first time approx.One hour into treatment for arterial pressures, machine checked and reset.Machine alarmed approx.2 more times through the next 2 hours of treatment, all for arterial pressure alarms.Having patient turn his head to the left relieved the pressure and treatment continued.With 7 minutes left on treatment the machine alarmed for arterial pressure, machine was reset then approx.30 seconds later re-alarmed for arterial pressure after reset alarmed for air in blood.Upon further examination air noted past venous clamp.And various air bubbles were noted in venous line heading towards patient.Machine was already stopped at this point, both arterial and venous lumens clamped, team leader notified.Pt disconnected from machine without returning his blood.Both lumens aspirated 10cc of blood, no air noted, then lumens flushed with ns.Patient remained asymptomatic.Np for nephrology notified.Biomed and team leader notified.Machine taken out of service.Biomed note: abd (automatic blood detection) device failed during the procedure.Replacement part ordered.
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Event Description
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Hemodialysis machine was set up correctly and passed all tests.The arterial and venous chambers were filled to the correct level before treatment initiated.Alarmed first time approx.One hour into treatment for arterial pressures, machine checked and reset.Machine alarmed approx.2 more times through the next 2 hours of treatment, all for arterial pressure alarms.Having patient turn his head to the left relieved the pressure and treatment continued.With 7 minutes left on treatment the machine alarmed for arterial pressure, machine was reset then approx.30 seconds later re-alarmed for arterial pressure after reset alarmed for air in blood.Upon further examination air noted past venous clamp.And various air bubbles were noted in venous line heading towards patient.Machine was already stopped at this point, both arterial and venous lumens clamped, team leader notified.Pt disconnected from machine without returning his blood.Both lumens aspirated 10cc of blood, no air noted, then lumens flushed with ns.Patient remained asymptomatic.Np for nephrology notified.Biomed and team leader notified.Machine taken out of service.Biomed note: abd (automatic blood detection) device failed during the procedure.Replacement part ordered.
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