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

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.

• 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 Key: 12553869
• MDR Text Key: 274013074
• Report Number: 12553869
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2021
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1