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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
Model Number 955630
Device Problems Material Twisted/Bent (2981); Pressure Problem (3012); Unexpected Shutdown (4019)
Patient Problem Insufficient Information (4580)
Event Date 03/17/2021
Event Type  malfunction  
Event Description
In spring 2021, a thermax blood warmer, component of a prismax continuous renal replacement therapy, had an produced error code 'thermax malfunction' (code t2292) while in patient use, causing the machine to shut down. It resulted from a pressure issue in the line exiting the top of the dialyzer cartridge, meaning that the line was kinked. The most likely reason for this is that when the line from the dialyzer was connected to the warmer cartridge it was done in such a way that twisted it, so that when the line warmed up and became softer it collapsed and kinked. Since this machine was still covered under warranty agreement due to recent purchase, a manufacturer field tech was dispatched to our site and verified proper operation of the machine by running two consecutive patient simulations, after which the service report was uploaded to our asset master and the machine was returned to service.
 
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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 Key11693255
MDR Text Key246274440
Report Number11693255
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 Risk Manager
Type of Report Initial
Report Date 03/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number955630
Device Catalogue Number955630
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/29/2021
Device Age10 MO
Event Location Hospital
Date Report to Manufacturer04/20/2021
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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