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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
Catalog Number 955630
Device Problems Defective Device (2588); Unintended Movement (3026)
Patient Problem Insufficient Information (4580)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
Thermax arms on crrt machines are defective and will not hold the machines in an upright position when not in use. Accidental bump or unleveling of the machine can cause therapy errors. Baxter will be called to replace the arm mechanism.
 
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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 Key13175476
MDR Text Key283307975
Report Number13175476
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
Type of Report Initial
Report Date 11/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number955630
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/23/2021
Date Report to Manufacturer01/06/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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