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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 Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2022
Event Type  malfunction  
Event Description
Patient's machine started to alarm "flow balance inaccurate" and "flow balance error" during his treatment and we were unable to clear this alarm.Rinseback was given and patient chose to leave instead of wait for another machine to be set up.He had 1 hour and 26 minutes left.Biomed was notified.Pa was also notified.Manufacturer response for hemodialysis unit, (brand not provided) (per site reporter).Agreed with repair plan.The root cause of the failure was the p2 pump output was not within standards.When i would complete the p2 test the reading were all over the place until i replaced the pump.
 
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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 Key15665628
MDR Text Key302359728
Report Number15665628
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 07/12/2022
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/12/2022
Event Location Other
Date Report to Manufacturer10/24/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/25/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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