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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION THERMAXTHERMAX BLOOD WARMER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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).
 
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Brand NameTHERMAXTHERMAX BLOOD WARMER
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 Key12576055
MDR Text Key274748729
Report Number12576055
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 09/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2021
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 FDA09/23/2021
Event Location Hospital
Date Report to Manufacturer10/05/2021
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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