MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION THERMAXTHERMAX BLOOD WARMER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problems Loose or Intermittent Connection (1371); Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Date 09/09/2021

Event Type  malfunction  

Event Description

The thermax is a blood warming device located on the side of the prismax crrt machine.There is an arm to keep the thermax upright against the side of the prismax machine while not in use to prevent damage.There are many sensors inside of the thermax that will impact its functionality if it is hit against something or not resting flat while in use.Out of 14 machines, in less than one year, we have had to request baxter replace 5 of the arms holding the thermax machine due to malfunction.The arm will not keep the thermax in an upright position, allowing it to fall freely.The thermax falling from the upright position takes it out of alignment creating a machine that does not rest flat while in use.It also creates a hazard during transport where the machine is easily hit against door frames and walls since the prismax/thermax will not fit through a standard doorway when the thermax is not in the upright position.The serial numbers of machines requiring baxter to replace the arm are as follows: (b)(4).

• Brand Name: THERMAXTHERMAX BLOOD WARMER
• 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 Key: 12576055
• MDR Text Key: 274748729
• Report Number: 12576055
• 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: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• 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: 09/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1