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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE CORPORATION PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number PHOENIX
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 05/31/2023
Event Type  malfunction  
Event Description
Error keeps popping up - high level in uf vessel error code # 73.Manufacturer response for hemodialysis, (brand not provided) (per site reporter).Found puf pump with seized roller (changed pump), original pump to the unit from 2011.Replaced solenoid evuf due to corrosion and possible leakage.Pulled burette, high- and low-level sensors, and cleaned and returned.Ran 2 separate patient sims for 30 minutes (passed), measured water removal on scale, set point.800ml, actual.812ml.Called baxter and talked with rep., i told her of all the circumstances and what i had completed, she agreed unit was ready for use after acknowledging passing 2 sims and the parts that were changed.Unit heat citric¿ed and bleach and rinse and returned for use.
 
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Brand Name
PHOENIX
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
one baxter parkway
deerfield IL 60015
MDR Report Key17097153
MDR Text Key316858698
Report Number17097153
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 06/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberPHOENIX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2023
Device Age13 YR
Event Location Hospital
Date Report to Manufacturer06/09/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/09/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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