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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO DASCO S.P.A., MONITORS DIVISION PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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GAMBRO DASCO S.P.A., MONITORS DIVISION PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 6023006700
Device Problem Defective Alarm (1014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2022
Event Type  malfunction  
Event Description
During patient hemodialysis tx (treatment) phoenix 3 kept having conductivity alarms.Attempted to fix alarm with no effect.Alarms caused large discrepancy between tx time and dialysis time causing post bun (common blood test, the blood urea nitrogen) labs not to be drawn.Patient has 3hrs run 3x per week.Patient came in alert and orientedx3 accompanied by mother.Vs (vital signs) stable.Noted only 0.5kg over dw (dry weight) but while on hd (hemodialysis) her crit line was on profile a.Able t challenge dw with good result.However, due to machine dysfunction unable to draw post bun lab because it would cause it to be in accurate.Machine pulled from floor and biomed notified.There was no harm in this event.
 
Event Description
During patient hemodialysis tx (treatment) phoenix 3 kept having conductivity alarms.Attempted to fix alarm with no effect.Alarms caused large discrepancy between tx time and dialysis time causing post bun (common blood test, the blood urea nitrogen) labs not to be drawn.Patient has 3hrs run 3x per week.Patient came in alert and orientedx3 accompanied by mother.Vs (vital signs) stable.Noted only 0.5kg over dw (dry weight) but while on hd (hemodialysis) her crit line was on profile a.Able t challenge dw with good result.However, due to machine dysfunction unable to draw post bun lab because it would cause it to be in accurate.Machine pulled from floor and biomed notified.There was no harm in this event.
 
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Brand Name
PHOENIX
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO DASCO S.P.A., MONITORS DIVISION
one baxter parkway
deerfield IL 60015
MDR Report Key13590939
MDR Text Key286067713
Report Number13590939
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 Other Health Care Professional
Type of Report Initial
Report Date 02/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6023006700
Device Catalogue Number103453
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/11/2022
Event Location Outpatient Treatment Facility
Date Report to Manufacturer02/24/2022
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age4745 DA
Patient SexFemale
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