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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER INTERNATIONAL INC. PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number PHOENIX
Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2022
Event Type  malfunction  
Event Description
Patient was running on dialysis machine for an hour and concentration type error a was going off.It would not clear.The wands were changed and port was cleaned but it still would not clear.No other machine was available at this time.Biomed was able to get another machine going.When doing set up with that machine it started leaking.Patient asked if he could leave today and come back tomorrow.Manager and np both updated and gave the ok for patient to come to dialysis another day and run last 2 hours.Manufacturer response for hemodialysis unit, (brand not provided) (per site reporter).Agreed with part replacement.
 
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Brand Name
PHOENIX
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER INTERNATIONAL INC.
one baxter parkway
deerfield IL 60015
MDR Report Key14712132
MDR Text Key294160921
Report Number14712132
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 02/15/2022
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/15/2022
Device Age8 YR
Event Location Hospital
Date Report to Manufacturer06/16/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/16/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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