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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER INTERNATIONAL INC. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Device Emits Odor (1425); Loss of Power (1475); Smoking (1585); Electrical Shorting (2926)
Patient Problem Insufficient Information (4580)
Event Date 09/01/2021
Event Type  malfunction  
Event Description
Patient was running on dialysis and had 10 minutes of treatment left. Dialysis machine went into general safe state and nurse noted a strong smell of burning plastic. Nurse clamped patient lines and shut off machine. Did not rinse patient blood back as she was concerned about a fire or safety of machine. Machine pulled from use and brought to biomed room for repair. Unit suddenly shut off with patient on the unit and unit. Manufacturer response for hemodialysis unit, (brand not provided) (per site reporter) troubleshot the problem down to the connection between the r1 regulator and the tube going into the regulator. Was spraying water in the pc pump enclosure which shorted out the circuit board. This short is what caused the board to burn/smoke to buildup. I contacted baxter tech support (service ticket (b)(4)). They agreed with my troubleshooting and agreed with my plan of repair. So i replaced the r1 regulator and the pc pump. Once replaced, i completed calibrations on the r2, r1, pc pump, d1, d2, and p2 pump. All passed with no discrepancies being noted. After the calibrations i ran a setup with a pa and puf auto cal. Performed a patient simulation for 30 minutes. Unit passed. Total amount removed according to unit: 800 ml-- measured amount 804. 7 ml (within 25ml +/-) completed a bleach/rinse. Unit returned to service.
 
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Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER INTERNATIONAL INC.
one baxter parkway
deerfield IL 60015
MDR Report Key12553869
MDR Text Key274013074
Report Number12553869
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 09/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/09/2021
Device Age7 YR
Event Location Hospital
Date Report to Manufacturer09/30/2021
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? No
Type of Device Usage Unkown

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