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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 Device Sensing Problem (2917); Infusion or Flow Problem (2964)
Patient Problem Insufficient Information (4580)
Event Date 04/23/2021
Event Type  malfunction  
Event Description
Ld1 level sensor failure- error 299. This error started soon after patient started on machine. Then 25 minutes into run, blood in dialysate -error 28 occurred. Patient rinsed back and moved to another machine. Machine put into rinse and pulled off the floor for biomed. Manufacturer response for hemodialysis, baxter (per site reporter). When the unit came in, i completed an operational check of the unit. While i was not able to get the unit to duplicate the problem. I did replace the bld sensor since the problem was intermittent. I ran a setup with a pa and puf auto cal and performed a patient simulation for 30 minutes. Unit passed. Total amount removed according to unit: 800 ml-- measured amount 807. 8 ml (within 25ml +/-) completed a bleach/rinse. Unit returned to service. Notified baxter of incident involving patient, and baxter had no further recommendations outside of the tests performed.
 
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Brand NamePHOENIX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
one baxter parkway
deerfield IL 60015
MDR Report Key12106678
MDR Text Key259639681
Report Number12106678
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 06/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 FDA06/10/2021
Device Age8 YR
Event Location Hospital
Date Report to Manufacturer07/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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