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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO DASCO SPA PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO DASCO SPA PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 6023006700
Device Problems Device Displays Incorrect Message (2591); Gas Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2022
Event Type  malfunction  
Event Description
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.
 
Event Description
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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Brand NamePHOENIX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO DASCO SPA
one baxter parkway
deerfield IL 60015
MDR Report Key13479488
MDR Text Key285245203
Report Number13479488
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6023006700
Device Catalogue Number103453
Device Lot Number9031356603
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/03/2022
Event Location Hospital
Date Report to Manufacturer02/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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