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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION THERMAX BLOOD WARMER DISPOSABLE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955516
Device Problems Fluid Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2022
Event Type  malfunction  
Manufacturer Narrative
Phone number: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous renal replacement therapy (crrt) with a prismax machine equipped with a thermax blood warmer, an external blood leak was observed from a hole in the luer connector. A clot formation was observed at the thermax blood warmer disposable the morning after start of treatment and an external blood leak was observed when attempting to wipe off the blood clot with a sterile swab. The treatment was ended with the extracorporeal blood being returned to the patient. Treatment was restarted with a new filter and new thermax blood warmer. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameTHERMAX BLOOD WARMER DISPOSABLE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - BROOKLYN PARK
7601 northland drive
n suite 170
minneapolis MN 55428
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key14121084
MDR Text Key289976730
Report Number3003504604-2022-00010
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K190910
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955516
Device Lot Number21C02
Was Device Available for Evaluation? No
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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