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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 Problems Material Integrity Problem (2978); Pressure Problem (3012); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2023
Event Type  malfunction  
Event Description
Unit alarmed 14, 44, and 65 while patient was connected.Unable to clear so patient had to be switched to another unit to continue treatment.Manufacturer response for hemodialysis, (brand not provided) (per site reporter) found pi transducer diaphragm hanging down, throwing bad pressures causing errors.Replaced pressure transducer and recalibrated.Ran patient sim without error.Called baxter and spoke with rep.And informed him of troubleshooting and end result.He gave me case#, and said if unit passed patient sim to return it to service.Returned unit to service.
 
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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 Key16426559
MDR Text Key310092890
Report Number16426559
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 01/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2023
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 FDA01/27/2023
Device Age7 YR
Event Location Hospital
Date Report to Manufacturer02/23/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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